Identity
- Trade Name
- NIPRO SYRINGE FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Model / Reference
- JD+01T2516 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00383790000673 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
Category: General-purpose syringe, single-use
Nipro Syringe by Nipro Medical Corporation — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
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- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191359 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173029 | Class II | Active |
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Manufacturer
- Manufacturer
- Nipro Medical Corporation
Sources (2)
- FDA UDI cbfa9c93-2a41-4b9c-821f-ed8e9f58a6de 58 fields · synced Jun 18, 2026
- FDA 510(k) K191359 1 fields · synced May 29, 2026