SF - Immunization Devices
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Product Details
Product name
PharmaJet® Tropis®
IMD-PQS Code
E008-071
Status
Prequalified
Date of acceptance
06 Apr 2018
Appliance type
E008
Product description
Single Use auto-disable needle-free jet injector
Manufacturer
PharmaJet, Inc.
Manufacturer Reference
PharmaJet® Tropis®
Country of Manufacture
United States of America
Address
400 Corporate Circle, Suite N
Golden
Colorado
United States of America
Golden
Colorado
United States of America
Telephone
+1 303 526-4278
Website address
Valid until
31 May 2026
Specifications
Product specifications - Main
Vaccine capacity (mL)
0.10
Graduations (ml)
0.10
Syringe material(s)
Other
Syringe Material(s) (Other)
Main materials of syringe: Polycarbonate. Material of adaptor: Polycarbonate
RUP mechanism
Prevented from reuse by: Plunger break before injection
Packaging & Sterility Assurance
Yes
Auto-disabling at:
Start of injection
AD Sub Category
Jet injector
AD Primary packaging
Blister pack
Price and shipping
Price 1
Contact manufacturer
Year of base price
2018
Quality standard
Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 7886-3; ISO 21649, CE 556625
Specification Reference
Applicable PQS specification: E008/JI01.1
Applicable PQS VP(s): E008/JI01-VP.1
Applicable PQS VP(s): E008/JI01-VP.1
Product Sites
PharmaJet, Inc.
400 Corporate Circle, Suite N
Golden,
Colorado
80401
United States of America
Document Details
The PharmaJet Tropis needle-free injection system is intended to deliver various medications and vaccines intradermally by means of narrow precise fluid stream, which penetrates the skin.
- Injector: Manufacturer reference C503-10. Administration: ID. Life time cycles: 20,000. Inadvertent activation prevention feature. Warranty 2 years.
- Needle-free Syringe: Manufacturer reference C503-38: 1-up pouches 50p, C503-34:1-up pouches,100/box, C503-35: 10-up pouches, 100/box, or C503-36: 20-up pouches, 200/box. Packaging: blister packs 1-up, 10-up or 20-up. Number of syringes per box: 50 units, 100 units of 200 units.
- Filling Adapter: Manufacturer reference C503-42: 1-up pouches. Compatibility only with the Tropis needle-free syringe. Intended for one vial use for field filling of syringes. Number of adapters per box: 50. Packaging: blister packs 1-up.
Note: Jet Injectors (single-use auto-disable needle-free syringe injectors) as medical devices (Class II) are regulated by National Regulatory Authorities. A Jet injector prequalified by the WHO PQS programme to deliver medications and vaccines is to be used according to label to deliver ONLY those medications and vaccines that have been approved by the relevant Authorities.