FDA UDI
In Commercial Distribution
🇺🇸 United States
Hematype Segment Device
DI: 10810020440536
·
Model: 4R5128
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Hematype Segment Device
- Primary DI
- 10810020440536
- Version / Model
- 4R5128
- Catalog Number
- 4R5128
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2022-11-08
- Public Version
- 2
- Public Version Date
- 2023-08-17
- Public Version Status
- Update
- Public Device Record Key
- 12c4724e-4713-485c-8388-94a901a3d2c0
Device Description
Hematype Segment Device
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810020440533 | GS1 | Carton | 2 | In Commercial Distribution | |
| Primary | 10810020440536 | GS1 | ||||
| Unit of Use | 00810020440539 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK960083 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature. Protect from freezing. Avoid excessive heat.