Identity
- Trade Name
- Waste bag 10 l FDA UDI
- Generic Name
- Autotransfusion system blood component processing set FDA UDI
- Device Name
- Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion set. FDA UDI
- Model / Reference
- 9006284 FDA UDI
- Description
- Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion set. FDA UDI
Identifiers
- Catalog Number
- 9006284 FDA UDI
- Primary DI / UDI-DI
- 04052682000522 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Autotransfusion system blood component processing set 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
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
Yes
FDA UDI
Category: Autotransfusion system blood component processing set
Waste bag 10 l by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Autotransfusion system blood component processing set.
- AUTOTRANSFUSION ACCESSORIES — SORIN GROUP ITALIA SRL · Class II
- autoLog® — MEDTRONIC, INC. · Class II
- HAEMONETICS PCS 2 APHERESIS SYSTEM — HAEMONETICS CORPORATION · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- PREASSEMBLED SURGICAL WASH SET — SORIN GROUP ITALIA SRL · Class II
- Compact Stat Pack — LivaNova USA, Inc.
- Electa Stat Pack — LivaNova USA, Inc.
- HAEMONETICS PCS 2 APHERESIS SYSTEM — HAEMONETICS CORPORATION · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI d1162379-8dda-4866-81c8-92627ed1b5cf 36 fields · synced May 30, 2026