FDA.reportPublic FDA data

NAR

Primary DI
00842209132515
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-4077
Catalog number
85-4077
Published
2024-08-14
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209132515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209132515008422091325158422091325150842209132515

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax dressingA sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209139620NAR84-0004A84-0004A2026-08-19
00842209139637NAR84-0007A84-0007A2026-08-19
00842209139644NAR84-0020A84-0020A2026-08-19
00842209139651NAR84-0023A84-0023A2026-08-19
00842209139668NAR84-0135A84-0135A2026-08-19
00842209139675NAR84-0138A84-0138A2026-08-19
00842209139682NAR80-1483A80-1483A2026-08-19
00842209139699NAR80-198580-19852026-08-19
00842209139705NAR84-020584-02052026-08-19
00842209139712NAR77-015377-01532026-08-19
00842209139729NAR82-0049P82-0049P2026-08-19
00842209139736NAR82-0051P82-0051P2026-08-19
00842209139743NAR82-0075P82-0075P2026-08-19
00842209139750NAR82-0077P82-0077P2026-08-19
00842209139767NAR80-1166P80-1166P2026-08-19
00842209139774NAR80-1593P80-1593P2026-08-19
00842209139781NAR80-1612P80-1612P2026-08-19
00842209139798NAR80-186980-18692026-08-19
00842209139804NAR80-189180-18912026-08-19
00842209139811NAR85-519685-51962026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05701780265058Biatain AdhesiveColoplast A/SNAD2026-08-27
04719873697779NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697786NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697793NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697809NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
00850088144925CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-08-14
040640351931573M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351931953M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
040640351932323M™ Tegaderm™3M Deutschland GmbHNAD2026-07-24
05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144659CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144697CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
00850088144215CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144222CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144239CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144246CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144253CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-08
00850088144000CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850088144017CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-03
00850087488686CeeportCEEPORT INC.NAD2026-06-30
06970206823946Dr Perfect Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206823977kegel Hydrocolloid DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22