Identity
- Trade Name
- Prefilled Syrings FDA UDI
- Generic Name
- Device-irrigation sterile water FDA UDI
- Device Name
- 10ML PREFILLED SYRINGE FDA UDI
- Model / Reference
- 11-1010 FDA UDI
- Description
- 10ML PREFILLED SYRINGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00369771003420 FDA UDI
- 510(k) Number
- K220060 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Device-irrigation sterile water 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Device-irrigation sterile water
Prefilled Syrings by Geri-Gentle Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Device-irrigation sterile water.
- TruCath — H R Pharmaceuticals, Inc. · Class II
- TruCath — H R Pharmaceuticals, Inc. · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- AquaFlate — H R Pharmaceuticals, Inc. · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
- AquaFlate — H R Pharmaceuticals, Inc. · Class II
Cleared under the same submission
K220060 also covers:
- Amxor VacFlush Pre-Filled Normal Saline Flush Syringe — Amxor Healthcare LLC
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp.
- Pre-Filled Saline Flush Syringes, Sterile, 10mL — Dynarex Corp.
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- GBUK — Jiangsu Caina Medical Co., Ltd
- ITL Biomedical — Jiangsu Caina Medical Co., Ltd
- ITL Biomedical — Jiangsu Caina Medical Co., Ltd
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- RELI® — MYCO MEDICAL SUPPLIES INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Geri-Gentle Corporation
Sources (1)
- FDA UDI cef5eea8-9f99-4a92-b6c8-26c5641a9956 34 fields · synced May 30, 2026