Identity
- Trade Name
- AMSafe ® Pre-Filled Normal Saline Flush Syringe FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, saline FDA UDI
- Device Name
- AMSafe ® Pre-Filled Normal Saline Flush Syringe , 10 mL 0.9% Sodium Chloride Injection, USP FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSafe ® Pre-Filled Normal Saline Flush Syringe , 10 mL 0.9% Sodium Chloride Injection, USP FDA UDI
Identifiers
- Catalog Number
- IVF1010TM FDA UDI
- Primary DI / UDI-DI
- 30704411015141 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, saline 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
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: Non-antimicrobial wound irrigation solution, saline
AMSafe ® Pre-Filled Normal Saline Flush Syringe by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-antimicrobial wound irrigation solution, saline.
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- SteriCare Solutions — NURSE ASSIST, INC. · U
- Premier Solution Saline Wound Wash — Premier Brands of America, Inc. · Class II
- NeilMed Wound Wash — NeilMed Pharmaceuticals Inc. · U
- SteriCare Solutions — NURSE ASSIST, INC. · U
- Caring Mill Saline Wound Wash — Caring Mill · 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
- Amsino International, Inc.
Sources (1)
- FDA UDI c5dd7e6e-db01-4696-9a43-e8d54123aa86 34 fields · synced May 31, 2026