Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- Starlyte III Fluid Pack FDA UDI
- Model / Reference
- E1-8 FDA UDI
- Description
- Starlyte III Fluid Pack FDA UDI
Identifiers
- Catalog Number
- E1-8 FDA UDI
- Primary DI / UDI-DI
- 00857969006365 FDA UDI
- GMDN Term
- Multiple electrolyte IVD, calibrator 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: Multiple electrolyte IVD, calibrator
Ace by Alfa Wassermann, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Calibrator 2 — TOKYO BOEKI MEDISYS INC. · Class II
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Dimension® QuikLYTE® Integrated Multisensor Standard A — Siemens Healthcare Diagnostics · 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 2e71af3a-0f23-48d1-9d83-b80b3697b457 36 fields · synced May 30, 2026