FDA UDI
In Commercial Distribution
🇺🇸 United States
Donor Tube Stripper
DI: 00810020440065
·
Model: 6R4452
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Donor Tube Stripper
- Primary DI
- 00810020440065
- Version / Model
- 6R4452
- Catalog Number
- 6R4452
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-04
- Public Version
- 1
- Public Version Date
- 2022-11-14
- Public Version Status
- New
- Public Device Record Key
- c4389cd8-2e06-47f1-b79a-439ff73a4adb
Device Description
Donor Tube Stripper
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 |
|---|---|---|---|---|
| 37851 | Blood tube stripper | A hand-held device designed to empty the blood contents of a section of tubing by compressing the tubing walls, typically to strip blood during blood collection or processing procedures, or for postsurgical blood removal. It is typically designed with proximal grip handles and two distal blades that join at a pivot point and which terminate in cylindrical roller bearings; when the handles are compressed the roller bearings are brought together thus squeezing the tubing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810020440065 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use chemical or abrasive cleaners or sharp edged tools for cleaning. Do not autoclave the Donor Tube Stripper.