FDA UDI
In Commercial Distribution
🇺🇸 United States
Clot catcher
DI: 05700699060167
·
Model: 906-016
·
Radiometer Medical ApS
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
Basic Information
- Brand Name
- Clot catcher
- Primary DI
- 05700699060167
- Version / Model
- 906-016
- Catalog Number
- 906-016
- Company Name
- Radiometer Medical ApS
- Labeler DUNS
- 308667539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 3
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- d5aa66c8-fbaf-424f-be1c-b3c59eda1e13
Device Description
Clot catcher, box of 400 pcs. for ABL5XX and ABL6XX
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | Clinical Chemistry | 862.1120 | 2 |
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
| CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | Clinical Chemistry | 862.1600 | 2 |
| JGS | ELECTRODE, ION SPECIFIC, SODIUM | Clinical Chemistry | 862.1665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66079 | Analyser blood clot protection filter IVD | A screening device intended to be placed in a blood specimen receptacle (e.g., capillary blood collection tube) prior to loading it into an in vitro diagnostic analyser (e.g., blood gas analyser) to trap blood clots and prevent them from entering the analyser. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700699060167 | GS1 | ||||
| Unit of Use | 55700699060162 | GS1 |
Customer Contacts
- Phone
- +459999999999
- [email protected]