FDA UDI
In Commercial Distribution
🇺🇸 United States
Fresenius Kabi Adjustable Automatic Donor Scale Support Stand
DI: 00810020440348
·
Model: Version A
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Fresenius Kabi Adjustable Automatic Donor Scale Support Stand
- Primary DI
- 00810020440348
- Version / Model
- Version A
- Catalog Number
- 4R4408
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-18
- Public Version
- 1
- Public Version Date
- 2021-08-26
- Public Version Status
- New
- Public Device Record Key
- becfc581-72b4-47a3-9648-9edd9a9c69fc
Device Description
Adjustable Automatic Donor Scale Support Stand
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| 45514 | Mechanical analytical balance | A mechanical laboratory instrument designed for weighing with a high degree of accuracy and precision. It will typically have a weighing range of up to 200 grams with a readability from 0.01 to 0.1 mg. The device will usually include an integrated weighing chamber. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810020440345 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00810020440348 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- For mobile operations, remove weight before transporting stand.