FDA UDI
In Commercial Distribution
🇺🇸 United States
rescuCLAMP™ Catheter Repair Clamp
DI: 36641670011528
·
Model: 1.5
·
Cardiomed Supplies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- rescuCLAMP™ Catheter Repair Clamp
- Primary DI
- 36641670011528
- Version / Model
- 1.5
- Catalog Number
- CM-604
- Company Name
- Cardiomed Supplies Inc
- Labeler DUNS
- 240623124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-04-21
- Public Version
- 1
- Public Version Date
- 2021-04-29
- Public Version Status
- New
- Public Device Record Key
- 0677ff50-29f4-4e8f-ba56-a0309990794b
Device Description
The Catheter Repair Clamp is designed with additional openings along the side and the top of the clamp to be quickly added or removed from tubing.
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FKK | Clamp, Line | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40589 | Medical tubing clip/clamp, temporary, non-calibrated, single-use | A manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 16641670011517 | GS1 | ||||
| Primary | 36641670011528 | GS1 |