FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMED
DI: 05060660971503
·
Model: P2524
·
Temed
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TEMED
- Primary DI
- 05060660971503
- Version / Model
- P2524
- Catalog Number
- P2524
- Company Name
- Temed
- Labeler DUNS
- 215842226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 2
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- de457d0e-0787-46c9-bbc6-68858e804caf
Device Description
TEMED Sucker Line The TEMED Suckers are single use, sterile devices that are intended for the extraction of bodily fluids and secretions, surgical tissue, debris and irrigation fluids from the surgical field into a filtered reservoir.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Cardiovascular | 870.4420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35441 | Cardiopulmonary bypass system blood tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060660971503 | GS1 | ||||
| Package | 05060660971756 | GS1 | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +441243572255
- [email protected]