Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Model / Reference
- 00884450156339 FDA UDI
Identifiers
- Catalog Number
- K02-00918 FDA UDI
- Primary DI / UDI-DI
- 00884450156339 FDA UDI
- FDA Product Code
- OEQ FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Merit Medical's General-purpose syringe, single-use device designed for various medical applications. This sterile and implantable device features a calibrated barrel with plunger intended for injection/withdrawal of fluids/gas, typically made of plastic and silicone materials with an anti-stick plunger.
Similar devices
Also classified as General-purpose syringe, single-use.
- SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
- KBMED — KB Medical (group), Inc. · Class II
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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 5222337f-1e0a-41ec-85cf-2df4f980fa30 33 fields · synced Jul 9, 2026