FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPOGUARD Advance Basic
DI: 04086000860888
·
Model: 9029741
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- COMPOGUARD Advance Basic
- Primary DI
- 04086000860888
- Version / Model
- 9029741
- Catalog Number
- 9029741
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-30
- Public Version
- 2
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- af6b771a-86be-474a-92f9-374e24a626de
Device Description
Device, Blood Mixing and Weighing
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSQ | Device, Blood Mixing And Blood Weighing | Hematology | 864.9195 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36405 | Blood donation rocker | An electromechanical device intended to be used during a blood donation procedure to agitate collected blood through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes (not included) which lie in a cradle-like holder. Additionally, it will typically be designed to weigh the collected blood, and may feature electronic controls for operating a clamping mechanism to secure blood collection tubing and stop/restart blood drawing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000860888 | GS1 |