Ultrasafe Passive Delivery

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BD UltraSafe Passive™ Needle Guard - BD

    https://drugdeliverysystems.bd.com/products/safety-and-shielding-systems/ultrasafe-passive-needle-guard
    The BD UltraSafe Passive™ needle guard for pre-filled ISO standard glass syringes supports injection with one-handed passive activation. The needle guard is suited for healthcare worker, caregiver and patient self-administration. The needle guard supports staked needles up to 5/8-in long.

BD UltraSafe Plus™ Passive Needle Guard - BD

    https://drugdeliverysystems.bd.com/products/safety-and-shielding-systems/ultrasafe-plus-passive-needle-guard
    The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility. The BD UltraSafe Plus passive needle guard enables passive activation for single-handed use.

510(k) Premarket Notification

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060743
    MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) Applicant: SAFETY SYRINGES, INC. 1939 PALOMAR OAKS WAY, SUITE A: carlsbad, CA 92009 Applicant Contact: thomas l hall: Correspondent: SAFETY SYRINGES, INC.

Passive - Food and Drug Administration

    https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060743.pdf
    1. Tamper Evident UltraSafe® PassiveTm Delivery System 2. UltraSafe® PassiveTM Delivery System (X-Series) (Subsequent to the submission of the premarket notification for this device, the trade name was changed from UltraSafe® Passive TM X-Series Needle Guard) Description of Modified Devices The Safety Syringes UltraSafe Delivery System ...

ENHANCING THE PATIENT EXPERIENCE FOR SELF-INJECTION ...

    https://www.ondrugdelivery.com/enhancing-the-patient-experience-for-self-injection-systems/
    Noble and BD’s collaboration for the BD UltraSafe includes a customisable demonstrator platform for manufacturers developing and launching drug delivery systems. BD UltraSafe is increasingly used to deliver self-injections across a breadth of therapies for diagnoses ranging from RA, osteoporosis and psoriasis to asthma and migraines, among ...

Bioavailability and Pharmacokinetics Study of Sirukumab in ...

    https://clinicaltrials.gov/ct2/show/NCT02079545
    Mar 05, 2014 · The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery ...

FDA Briefing Document Arthritis Advisory Committee Meeting ...

    https://www.fda.gov/media/106325/download
    A prefilled syringe fitted with UltraSafe Passive™ Delivery System (PFS-U), a single-use, sterile, ready-to-use liquid-filled 1-mL syringe product supplied with a passive

A Study to Assess the Pharmacokinetic ... - PatientsLikeMe

    https://www.patientslikeme.com/clinical_trials/NCT01866007-Healthy-Guselkumab-CNTO1959-Pharmacokinetics-UltraSafe-Passive-Delivery-System-PFS-U-Prefilled-syringe-facilitated-injection-device-PFS-FID
    Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

BD UltraSafe Plus™ Passive Needle Guard - Avin Darou

    http://avindarou.ir/products/bd-ultrasafe-plus-passive-needle-guard/
    The BD UltraSafe Plus passive need le guard is ergonomically designed to support delivery of higher-viscosity drugs and patient self-administration.. Advanced ergonomics:; The BD UltraSafe Plus passive needle guard is designed for self-administration, supporting patient-controlled injection.

UltraSafe Passive® Needle Guard A Makrolon® case study ...

    https://solutions.covestro.com/en/highlights/articles/cases/2019/ultrasafe-needle-guard
    BD’s UltraSafe Passive® Needle Guards are composed of two telescoping thermoplastic components and a spring. To manufacture the device, BD required a material that was not only strong, durable and transparent, but one that had precisely the right flow characteristics to ensure easy release from the mold.

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