Identity
- Trade Name
- J-Tip FDA UDI
- Generic Name
- Needleless medication/vaccine injector, mechanical FDA UDI
- Device Name
- J-Tip Needleless Injector System is used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for the injection using jet injection or needleless injection systems. For subcutaneous injection only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitionin medications with needle and syringe. FDA UDI
- Model / Reference
- 8164200125 FDA UDI
- Description
- J-Tip Needleless Injector System is used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for the injection using jet injection or needleless injection systems. For subcutaneous injection only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitionin medications with needle and syringe. FDA UDI
Identifiers
- Catalog Number
- 8164-2001-25 FDA UDI
- Primary DI / UDI-DI
- B07281641001 FDA UDI
- FDA Product Code
- KZE FDA UDI
- GMDN Term
- Needleless medication/vaccine injector, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.25 Milliliter FDA UDI
Category: Needleless medication/vaccine injector, mechanical
J-Tip by National Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- National Medical Products, Inc.
Sources (1)
- FDA UDI 0ac4519b-d9fc-49d1-9bcc-2d4a6399ec66 37 fields · synced Jun 6, 2026