FDA.reportPublic FDA data

Cardiac Insulation Pad Adult Sterile

Primary DI
05391530750141
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
989772017
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391530754033Polycarbonate SyringeFD-1098NS 3ml PC Syringe Dark Green PlungerFD-1098NS 3ml PC Syringe Dark Green Plunger2026-09-27
05391530754057Polycarbonate SyringeFD-1097NS 3ml PC Syringe Light Green PlungerFD-1097NS 3ml PC Syringe Light Green Plunger2026-09-27
05391530754118Polycarbonate SyringeFD-1068NS 3ml PC Syringe Red Plunger Nitro PrintFD-1068NS 3ml PC Syringe Red Plunger Nitro Print2026-09-27
05391530754149polycarbonate syringe6ml PC Syringe Light Green Plunger - Non-Sterile6ml PC Syringe Light Green Plunger - Non-Sterile2026-09-27
05391530754170polycarbonate syringeFD-1099NS 6ml PC Syringe Yellow PlungerFD-1099NS 6ml PC Syringe Yellow Plunger2026-09-27
05391530754255polycarbonate syringeFD-1105NS 20ml PC Syringe with Dark Green PlungerFD-1105NS 20ml PC Syringe with Dark Green Plunger2026-09-27
05391530754279polycarbonate syringe20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 20ml PC Syringe Light Blue Plunger HEPARIN/SALINE 2026-09-27
05391530754286polycarbonate syringeFD-1104NS 20ml PC Syringe with Light Green PlungerFD-1104NS 20ml PC Syringe with Light Green Plunger2026-09-27
05391530754323polycarbonate syringe30ml PC Syringe White Plunger30ml PC Syringe White Plunger2026-09-27
05391530754385polycarbonate syringesFD-1079NS 10ml PC Syringe Purple Plunger Heparin PFD-1079NS 10ml PC Syringe Purple Plunger Heparin P2026-09-27
05391530754415polycarbonate syringeFD-1037NS 10ml PC Syringe Light Blue Plunger HeparFD-1037NS 10ml PC Syringe Light Blue Plunger Hepar2026-09-27
05391530754477polycarbonate syringeFD-1041NS 10ml PC Syringe Light Green Plunger HepaFD-1041NS 10ml PC Syringe Light Green Plunger Hepa2026-09-27
05391530754484polycarbonate syringe10ml PC Syringe Light Green Plunger Lidocaine Prin10ml PC Syringe Light Green Plunger Lidocaine Prin2026-09-27
05391530754651polycarbonate syringesFD-1053NS 10ml PC Syringe Yellow Plunger Nitro PriFD-1053NS 10ml PC Syringe Yellow Plunger Nitro Pri2026-09-27
05391530754736polycarbonate syringe10ml PC syringe white plunger Lidocaine print10ml PC syringe white plunger Lidocaine print2026-09-27
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

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