SF - Immunization Devices
Product Details
WHO Product ID
E008-050
Status
Prequalified
Date of acceptance
Type
E008: Injection devices for immunization
Product Desc
single-use auto-disable needle-free jet injector
Appliance Type
E008
Manufacturer
PharmaJet, Inc.
400 Corporate Circle, Suite N Golden, Colorado 80401 USA
United States of America
Valid until
Specifications
Product identification
Manufacturers Reference
Pharmajet Stratis®
Country of Manufacture
United States of America
Product specifications - Main
Graduations (ml)
0.50
Markings
FDA 510(k); CE 556625
RUP mechanism
Plunger break
AD Primary packaging
Blister pack
Price and shipping
Shipping volume (m3)
0.037
Price 1
Upon request to mfr
Year of base price
2012
Incoterms
EXW
Quality standard
Quality Standard
ISO 13485
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 USA
United States of America
Document Details
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