FDA.reportPublic FDA data

rescuCLAMP™ Catheter Repair Clamp

Primary DI
36641670011528
Brand
rescuCLAMP™ Catheter Repair Clamp
Company
Cardiomed Supplies Inc
Model
1.5
Catalog number
CM-604
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.
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FKKClamp, Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKKClamp, LineGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36641670011528PrimaryGS10
16641670011517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3664167001152836641670011528
1664167001151716641670011517

GMDN Terms#

Term, Definition table
TermDefinition
Medical tubing clip/clamp, temporary, non-calibrated, single-useA 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.

Regulatory Flags#

DUNS number
240623124
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36641670001314Adult Heart Cooling Jacket2.417-2602021-04-21
36641670001338Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
36641670001352Pediatric Heart Cooling Jacket2.017-2622021-04-21
36641670019241Drop-It™ Quick Release Needle Holders1.145502021-04-21
16641670001303Adult Heart Cooling Jacket2.417-2602021-04-21
16641670001327Adult Heart Cooling Jacket Recirculation Set1.417-260TG2021-04-21
16641670001341Pediatric Heart Cooling Jacket2.017-2622021-04-21
16641670011517rescuCLAMP™ Catheter Repair Clamp1.5CM-6042021-04-21
16641670019230Drop-It™ Quick Release Needle Holders1.145502021-04-21
366416700041793/8'' x 1/4'' x 3/8'' Y Connector2.9C-6602020-12-02
366416700041931/2'' x 3/8'' x 3/8'' Y Connector2.8C-6612020-12-02
366416700042163/8'' x 1/4'' x 1/4'' Y Connector2.0C-6622020-12-02
366416700042301/2'' x 3/8'' x 1/2'' Y Connector2.4C-6632020-12-02
366416700042541/4'' Y Connector w/L.L.2.6C-6642020-12-02
366416700042783/8'' Y Connector w/L.L.2.6C-6652020-12-02
366416700042921/2'' Y Connector w/L.L.1.4C-6662020-12-02
366416700043153/16'' Y Connector w/L.L.1.5C-6672020-12-02
366416700043393/8'' x 1/4'' x 3/8'' Y Connector w/L.L.1.3C-6682020-12-02
366416700043531/2'' x 3/8'' x 3/8'' Y Connector w/L.L.1.6C-6692020-12-02
366416700043773/8'' x 1/2'' x 1/2'' Y Connector w/L.L.2.3C-6702020-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208233ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
57332414208238ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
13700911900928Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900935Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900942Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900925Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900932Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900949Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900621Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900638Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900645Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900628Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900635Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900642Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
16641670011517rescuCLAMP™ Catheter Repair ClampCardiomed Supplies IncFKK2021-04-21
00852250006093Lifemed Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00852250006109Lifemed Coated Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00085412025360NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
00085412070643ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412025365NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412070648ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15