SF - Immunization Devices
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Product Details
Product name
Pharmajet Stratis®
IMD-PQS Code
E008-050
Status
Prequalified
Date of acceptance
31 Jan 2013
Appliance type
E008
Product description
Single-use auto-disable needle-free jet injector
Manufacturer
PharmaJet, Inc.
Manufacturer Reference
Pharmajet Stratis®
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)
0.50
Graduations (ml)
0.50
Markings
FDA 510(k); CE 556625
Syringe material(s)
Other
Syringe Material(s) (Other)
Injector: ABS; stainless steel. Material of adapter & syringe: Polycarbonate
RUP mechanism
Plunger break
Packaging & Sterility Assurance
Yes
AD Number pieces
2 pieces
Auto-disabling at:
Start of injection
AD Sub Category
Jet injector
AD Primary packaging
Blister pack
Price and shipping
Shipping volume (m3)
0.037
Weight per package (Kg)
3.2300
Pieces per package
1
Price 1
Upon request to mfr
Year of base price
2012
Incoterms
EXW
Quality standard
Quality Standard
ISO 13485;Other
Quality standard (Other)
ISO 7886-3; FDA 510(k); 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
- Reset station Injector: Reference manufacturer C501-20. Lifetime sysles: 20,000 min. Carrying case IP: 55
- Needle free syringe: Reference manufacturer C501-32 & C501-34
- Filling adapter: Reference manufacturer C501-43 & C501-46. Compatibility only with the Stratis needle-free syringe. Intended for one vial use for field- set filling of syringes.
- Injector: Reference manufacturer C501-10. Inadvertent actuation Blister pack prevention feature
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.
Minimum order (units): 1 set
Units per package: Syringes, 250/box; adaptors, 75/box
Warranty: 2 years