FDA.reportPublic FDA data

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
05391530754941NuGen syringeFD-1180NS 3ml Nugen Syringe - Red PlungerFD-1180NS 3ml Nugen Syringe - Red Plunger2026-06-03
05391530754965NuGen syringeFD-1162NS 10ml Nugen Syringe - Red PlungerFD-1162NS 10ml Nugen Syringe - Red Plunger2026-06-03
05391530753814NuGen syringeFD-1036NS - 30ml PC Syringe - Blue PlungerFD-1036NS - 30ml PC Syringe - Blue Plunger2026-06-01
05391530753876NuGen syringeFD-1159NS - 1ml Nugen Syringe - White PlungerFD-1159NS - 1ml Nugen Syringe - White Plunger2026-06-01
05391530753890NuGen syringeFD-1172NS - 1ml Nugen Syringe - Blue PlungerFD-1172NS - 1ml Nugen Syringe - Blue Plunger2026-06-01
05391530753913NuGen syringeFD-1165NS - 10ml Nugen Syringe - Purple PlungerFD-1165NS - 10ml Nugen Syringe - Purple Plunger2026-06-01
05391530753852NuGen syringeFD-1167NS 3ml Nugen Syringe - Blue PlungerFD-1167NS 3ml Nugen Syringe - Blue Plunger2026-05-31
05391530753944Polycarbonate syringeFD-1017NS -1ml PC Syringe White PlungerFD-1017NS -1ml PC Syringe White Plunger2026-06-03
05391530753951Polycarbonate syringeFD-1018NS - 1ml PC Syringe - Blue SyringeFD-1018NS - 1ml PC Syringe - Blue Syringe2026-06-03
05391530754217Polycarbonate syringeFD-1078NS 20ml PC Syringe - White Plunger - SalineFD-1078NS 20ml PC Syringe - White Plunger - Saline2026-06-03
05391530754620Polycarbonate syringeFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699Polycarbonate syringeFD-1075NS 10ml PC Syringe - Light Blue Plunger XylFD-1075NS 10ml PC Syringe - Light Blue Plunger Xyl2026-06-03
05391530753968Polycarbonate syringeFD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC Syringe - Yellow Plunger2026-06-02
05391530754088Polycarbonate syringeFD-1021NS 3ml PC Syringe - White PlungerFD-1021NS 3ml PC Syringe - White Plunger2026-06-02
05391530754194Polycarbonate syringeFD-1034NS 20ml PC Syringe - Red PlungerFD-1034NS 20ml PC Syringe - Red Plunger2026-06-02
05391530754224Polycarbonate syringeFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231Polycarbonate syringeFD-1092NS 20ml PC Syringe Heparin Print - Red PlunFD-1092NS 20ml PC Syringe Heparin Print - Red Plun2026-06-02
05391530753456Polycarbonate syringeFD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NS - 20ml PC Syringe Blue Plunger2026-06-01
05391530753463Polycarbonate syringeFD-1031NS - White PlungerFD-1031NS - 20ml PC Syringe White Plunger2026-06-01
05391530753487Polycarbonate syringeFD-1113NS - 10ml PC Syringe Contrast Dark Green PlFD-1113NS - 10ml PC Syringe Contrast Dark Green Pl2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25
08033178019378Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
08033178019385Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
00199150083855NAMEDTRONIC, INC.DWF2026-06-08
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30