Identity
- Trade Name
- CompoGuard Complete (NA) FDA UDI
- Generic Name
- Blood donation rocker FDA UDI
- Device Name
- Device, Blood Mixing and Weighing FDA UDI
- Model / Reference
- 9029661 FDA UDI
- Description
- Device, Blood Mixing and Weighing FDA UDI
Identifiers
- Catalog Number
- 9029661 FDA UDI
- Primary DI / UDI-DI
- 04086000860765 FDA UDI
- FDA Product Code
- KSQ FDA UDI
- GMDN Term
- Blood donation rocker FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9195 FDA UDI
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood donation rocker
CompoGuard Complete (NA) by Fresenius Kabi — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood donation rocker.
- HemoMix 3 — DELCON SRL · Class II
- HemoMix 3 — DELCON SRL · Class II
- MacoMix HM20 and Hemolog 6 — MACO PHARMA · Class II
- Blood Collection Monitor CM350 — CENTRON CORPORATION · Class I
- Boekel Blood Collection Mixer — BOEKEL INDUSTRIES, INC. · Class I
- Blood Collection Mixer CM735A — CENTRON CORPORATION · Class I
- Data Collection Mixer DCM3000 (BASIC) — CENTRON CORPORATION · Class I
- COMPOGUARD Advance Basic — Fresenius Kabi · Class I
Cleared under the same submission
BK040005 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 0a5c1c2d-24a2-4ca0-9fbe-bb9556857dd7 35 fields · synced May 30, 2026