Identity
- Trade Name
- EXACTAMIX FDA UDI
- Generic Name
- Compounding transfer set FDA UDI
- Device Name
- EXACTAMIX Inlet, Syringe Inlet FDA UDI
- Model / Reference
- H938176 FDA UDI
- Description
- EXACTAMIX Inlet, Syringe Inlet FDA UDI
Identifiers
- Catalog Number
- H938176 FDA UDI
- Primary DI / UDI-DI
- 00085412475813 FDA UDI
- 510(k) Number
- K002705 FDA UDI
- FDA Product Code
- LHI FDA UDINEP FDA UDI
- GMDN Term
- Compounding transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Compounding transfer set
Exactamix by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002705 also covers:
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — BAXTER CORPORATION ENGLEWOOD
- EXACTAMIX — Baxter Healthcare Corp
- EXACTAMIX — Baxter Healthcare Corp
- EXACTAMIX — Baxter Healthcare Corp
- EXACTAMIX — Baxter Healthcare Corp
- EXACTAMIX — Baxter Healthcare Corp
- EXACTAMIX — Baxter Healthcare Corp
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
- Baxter Healthcare Corp
Sources (1)
- FDA UDI df47c7d3-448f-4f37-8dfa-3940d28c0130 36 fields · synced May 30, 2026