FDA.reportPublic FDA data

NAR Kit

Primary DI
00842209105373
Brand
NAR Kit
Company
NORTH AMERICAN RESCUE, LLC
Model
83-0020
Catalog number
83-0020
Device description
KIT, PFC FOLEY
Published
2018-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PPBFoley Catheter Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209105373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209105373008422091053738422091053730842209105373

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Regulatory Flags#

DUNS number
832426782
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00842209128198NAR83-003583-00352023-08-10
00842209105083NAR Kit83-001483-00142018-09-14
00842209105090NAR83-001583-00152018-09-14
00842209105342NAR Kit83-000783-00072018-09-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253068191DoverCardinal Health 200, LLCPPB2026-01-15
10192253068207DoverCardinal Health 200, LLCPPB2026-01-15
10192253030525DoverCardinal Health 200, LLCPPB2024-12-20
10192253030532DoverCardinal Health 200, LLCPPB2024-12-20
10193489987126Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489987133Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
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10193489988529Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
10193489988611Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
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10193489987683Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
10193489987690Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2022-11-30
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