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
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerFD-1017NS -1ml PC SyringeFD-1017NS -1ml PC Syringe2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerFD-1018NS - 1ml PC SyringeFD-1018NS - 1ml PC Syringe2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintFD-1078NS 20ml PC SyringeFD-1078NS 20ml PC Syringe2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineFD-1075NS 10ml PC SyringeFD-1075NS 10ml PC Syringe2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeFD-1180NS 3ml Nugen SyringeFD-1180NS 3ml Nugen Syringe2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerFD-1162NS 10ml Nugen SyringeFD-1162NS 10ml Nugen Syringe2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC SyringeFD-1019NS - 1ml PC Syringe2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerFD-1021NS 3ml PC SyringeFD-1021NS 3ml PC Syringe2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerFD-1034NS 20ml PC SyringeFD-1034NS 20ml PC Syringe2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerFD-1092NS 20ml PC SyringeFD-1092NS 20ml PC Syringe2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NSFD-1032NS2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerFD-1031NSFD-1031NS2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerFD-1113NS - 10ml PC SyringeFD-1113NS - 10ml PC Syringe2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintFD-1051NS - 10ml PC SyringeFD-1051NS - 10ml PC Syringe2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerFD-1043NS - 10ml PC SyringeFD-1043NS - 10ml PC Syringe2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerFD-1107NS - 30ml PC SyringeFD-1107NS - 30ml PC Syringe2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerFD-1026NS - 10ml PC SyringeFD-1026NS - 10ml PC Syringe2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerFD-1158NS - 10ml PC SyringeFD-1158NS - 10ml PC Syringe2026-06-01

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Primary DI, Brand, Company table
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