Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- SYRINGE, 5ML SALINE IN 10ML FDA UDI
- Model / Reference
- EMZ151240 FDA UDI
- Description
- SYRINGE, 5ML SALINE IN 10ML FDA UDI
Identifiers
- Catalog Number
- EMZ151240 FDA UDI
- Primary DI / UDI-DI
- 10888277664333 FDA UDI
- 510(k) Number
- K173348 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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: Irrigation syringe
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
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- Dover — Cardinal Health 200, LLC · Class I
- PROBEVAC — PLASDENT CORP. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Monoject — Cardinalhealth · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
Cleared under the same submission
K173348 also covers:
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 4966073d-43c9-4b61-a09c-12e058fddd42 36 fields · synced May 31, 2026