Identity
- Trade Name
- Precise FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Precise Separation Canister, 120 mL FDA UDI
- Model / Reference
- AMS50035-050 FDA UDI
- Description
- Precise Separation Canister, 120 mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- M896AMS500350500 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
Yes
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: Haematological concentrate system preparation kit, platelet concentration
Precise by Arteriocyte Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK200540 also covers:
- Precise — Arteriocyte Medical Systems, Inc.
- Precise — Arteriocyte Medical Systems, Inc.
- Precise — Arteriocyte Medical Systems, Inc.
- Precise — Arteriocyte Medical Systems, Inc.
- Precise — Arteriocyte Medical Systems, Inc.
- Precise Diamond — Arteriocyte Medical Systems, Inc.
- Precise Diamond — Arteriocyte Medical Systems, Inc.
- Precise Sapphire — Arteriocyte Medical Systems, Inc.
- Precise Sapphire — Arteriocyte Medical Systems, Inc.
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
- Arteriocyte Medical Systems, Inc.
Sources (1)
- FDA UDI 15859b37-811f-4b0c-b281-e4f42f895b86 34 fields · synced May 30, 2026