FDA UDI
In Commercial Distribution
🇺🇸 United States
Perfusion Clamp with Adaptor
DI: 13700911900942
·
Model: PC1025A
·
INSTITUT GEORGES LOPEZ
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Perfusion Clamp with Adaptor
- Primary DI
- 13700911900942
- Version / Model
- PC1025A
- Company Name
- INSTITUT GEORGES LOPEZ
- Labeler DUNS
- 393146183
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-18
- Public Version
- 1
- Public Version Date
- 2024-10-28
- Public Version Status
- New
- Public Device Record Key
- 863a7597-991e-4829-89b3-652d5e84ea6e
Device Description
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FKK | Clamp, Line | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48039 | Kidney donor-organ preservation/transport perfusion set | A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23700911900949 | GS1 | Carton Box | 15 | In Commercial Distribution | |
| Primary | 13700911900942 | GS1 | ||||
| Package | 53700911900940 | GS1 | Carton Box | 4 | In Commercial Distribution | |
| Package | 33700911900946 | GS1 | Carton Box | 15 | In Commercial Distribution |