Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Isotonic saline reagent IVD FDA UDI
- Device Name
- NORMAL SALINE DILUENT FDA UDI
- Model / Reference
- SA1020 FDA UDI
- Description
- NORMAL SALINE DILUENT FDA UDI
Identifiers
- Catalog Number
- SA1020 FDA UDI
- Primary DI / UDI-DI
- 00857969006624 FDA UDI
- GMDN Term
- Isotonic saline reagent IVD FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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: Isotonic saline reagent IVD
Ace by Alfa Wassermann, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Isotonic saline reagent IVD.
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- Thermo Scientific Nerl® — Fisher Diagnostics · Class I
- SP — Cardinal Health 200, LLC · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI 4b0f8239-892c-4903-80e1-125ed510d71a 36 fields · synced May 29, 2026