Cardiac Insulation Pad Adult Sterile

Primary DI
05391530750127
Brand
Cardiac Insulation Pad Adult Sterile
Company
DMC MEDICAL LIMITED
Model
Adult - Sterile
Catalog number
FD-1001
Device description
Cardiac Insulation Pad Adult Sterile
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992932000CIPA (ADULTS) CIPI (INFANTS)Dmc Medical, Ltd.2000-06-07DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750134PackageGS110In Commercial Distribution
05391530750141PackageGS18In Commercial Distribution
05391530750127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750134053915307501345391530750134
05391530750141053915307501415391530750141
05391530750127053915307501275391530750127

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac insulation padA thin and pliable cushion designed to be placed around the heart in conjunction with cold cardioplegia during cardiac surgery with extracorporeal circulation. The device is intended to help to prevent rapid rewarming of the heart. This is a single-use device.

Regulatory Flags#

DUNS number
989772017
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530750035SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHgSVDS200FD-10032016-08-10
05391530750066SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHgSVDS300FD-10042016-08-10
05391530750097Vein Irrigation Cannula DMC VIC SterileDMC VIC STERILEFD-10062016-08-10
053915307501581ml Insulin Suresafe Syringe"1ml Insulin Syringe - 29G x 1/2"""FD-SSFX01L-292016-08-11
053915307501891ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 27G x 1/2"""FD-SSFX01L-272016-08-11
053915307502191ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 5/8"""FD-SSFX01T-252016-08-11
053915307502401ml Tuberculin Suresafe Syringe"1ml Tuberculin Syringe - 25G x 1"""FD-SSFX01T-25-012016-08-11
05391530750271Suresafe 1ml Syringe"1ml Syringe - 25G x 5/8"""FD-SSFX01-252016-08-11
05391530750301Suresafe 1ml Syringe"1ml Syringe - 25G x 1"""FD-SSFX01-25-012016-08-11
053915307503323ml Suresafe Syringe"3ml Syringe - 25G x 5/8"""FD-SSIC03-252016-08-12
053915307503633ml Suresafe Syringe"3ml Syringe - 25G x 1"""FD-SSIC03-25-012016-08-12
053915307503943ml Suresafe Syringe"3ml Syringe - 23G x 1"""FD-SSIC03-232016-08-12
053915307504243ml Suresafe Syringe"3ml Syringe - 23G x 1 1/2"""FD-SSIC03-23-012016-08-12
053915307504553ml Suresafe Syringe"3ml Syringe - 22G x 1 1/2"""FD-SSIC03-222016-08-12
053915307504863ml Suresafe Syringe"3ml Syringe - 21G x 1"""FD-SSIC03-212016-08-12
053915307505163ml Suresafe Syringe"3ml Syringe - 22G x 1"""FD-SSIC03-22-012016-08-12
053915307505473ml Suresafe Syringe"3ml Syringe - 21G x 1 1/2"""FD-SSIC03-21-012016-08-12
053915307505785ml Suresafe Syringe"5ml Syringe - 21G x 1 1/2"""FD-SSIC05-212016-08-12
053915307506085ml Suresafe Syringe"5ml Syringe - 22G x 1 1/2"""FD-SSIC05-222016-08-11
0539153075063910ml Suresafe Syringe"10ml Syringe - 22G x 1 1/2"""FD-SSIC10-222016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
08033178019620Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019637Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019644Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019651Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019668Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019675Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019057Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019064Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019071Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019088Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019095Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019101Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019118Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11