Identity
- Trade Name
- SP FDA UDI
- Generic Name
- Isotonic saline reagent IVD FDA UDI
- Device Name
- SP Brand Immu-Sal Saline; For Use in Immunohematological Procedures; For In Vitro Diagnostic Use; For Laboratory Use Only; Not Intended For Internal Use; Not for Infusion, Injection, Irrigation, or Ingestion; 2.5 gal FDA UDI
- Model / Reference
- B5052-25 FDA UDI
- Description
- SP Brand Immu-Sal Saline; For Use in Immunohematological Procedures; For In Vitro Diagnostic Use; For Laboratory Use Only; Not Intended For Internal Use; Not for Infusion, Injection, Irrigation, or Ingestion; 2.5 gal FDA UDI
Identifiers
- Catalog Number
- B5052-25 FDA UDI
- Primary DI / UDI-DI
- 00630140058861 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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: Isotonic saline reagent IVD
Sp by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ACE — Alfa Wassermann, Inc.
- 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 7af3f1c5-f9a6-45b4-9b89-75144a822cd7 35 fields · synced Jun 8, 2026