AccessGUDID - DEVICE: rescuCLAMP™ Catheter Repair Clamp (36641670011528)

GUDID

Device Identifier (DI) Information

Brand Name: rescuCLAMP™ Catheter Repair Clamp
Version or Model: 1.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM-604
Company Name: Cardiomed Supplies Inc

Primary DI Number: 36641670011528
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 240623124 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKK	Clamp, Line

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0677ff50-29f4-4e8f-ba56-a0309990794b
Public Version Date: April 29, 2021
Public Version Number: 1
DI Record Publish Date: April 21, 2021