FDA.reportPublic FDA data

NAR

Primary DI
00842209136025
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-4946
Catalog number
85-4946
Device description
PPE KIT
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PXCPersonal Protection Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXCPersonal Protection KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209136025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209136025008422091360258422091360250842209136025

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209138760NAR77-014377-01432026-05-27
00842209138777NAR77-014477-01442026-05-27
00842209138784NAR77-014577-01452026-05-27
00842209138791NAR77-014677-01462026-05-27
00842209138807NAR77-014777-01472026-05-27
00842209138814NAR77-014877-01482026-05-27
00842209138821NAR77-014977-01492026-05-27
00842209138838NAR77-015077-01502026-05-27
00842209138845NAR77-015177-01512026-05-27
00842209138852NAR80-0299A80-0299A2026-05-27
00842209138869NAR80-0452A80-0452A2026-05-27
00842209138876NAR80-0453A80-0453A2026-05-27
00842209138883NAR80-0523A80-0523A2026-05-27
00842209138890NAR80-0947A80-0947A2026-05-27
00842209138906NAR80-1034A80-1034A2026-05-27
00842209138913NAR82-0049A82-0049A2026-05-27
00842209138920NAR82-0053A82-0053A2026-05-27
00842209138937NAR80-1907A80-1907A2026-05-27
00842209138944NAR80-192980-19292026-05-27
00842209138951NAR80-198180-19812026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717120070Regard™ROI CPS, LLCPXC2024-10-02
10194717120131Regard™ROI CPS, LLCPXC2024-10-02
20194717120077Regard™ROI CPS, LLCPXC2024-10-02
20194717120138Regard™ROI CPS, LLCPXC2024-10-02
10194717119913Regard™ROI CPS, LLCPXC2024-08-14
20194717119910Regard™ROI CPS, LLCPXC2024-08-14
10194717119746Regard™ROI CPS, LLCPXC2024-06-20
20194717119743Regard™ROI CPS, LLCPXC2024-06-20
00842209130665NARNORTH AMERICAN RESCUE, LLCPXC2024-04-29
10194717116042Regard™ROI CPS, LLCPXC2022-07-11
20194717116049Regard™ROI CPS, LLCPXC2022-07-11
M7526892650STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-21
M7526871050STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-17
M7526894290STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-14
M7526891530STRADIS HEALTHCARESTRADIS MEDICAL, LLCPXC2022-03-02
00612479259102McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259126McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259119McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00612479259133McKessonMCKESSON MEDICAL-SURGICAL INC.PXC2022-02-03
00816703025727MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403338MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403369MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703025734MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403345MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00840155403376MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-08-03
00816703028544MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028568MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028582MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028605MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22
00816703028551MedSource GlovesMEDSOURCE INTERNATIONAL LLCPXC2021-07-22