FDA.reportPublic FDA data

TravelJohn® Resealable

Primary DI
10671504669184
Brand
TravelJohn® Resealable
Company
Reach Global Industries, Inc.
Model
TJ1N-C 66918C
Catalog number
66918C
Device description
TravelJohn® Resealable Disposable Urinal Bags, 3-Pack US version
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FNPUrinal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNPUrinalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00671504669187PrimaryGS10
10671504669184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00671504669187006715046691876715046691870671504669187
1067150466918410671504669184

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held urinal, single-useA portable, hand-held container intended to be directly urinated into by a patient for excretory purposes; it may be specific to male or female patients, or unisex. It is typically in the form of a bottle with a handle, or a bag, or pouch; it may include a noninvasive funnel and tubing, and may have a drain with a stopper in it to facilitate emptying. It is not intended to be worn by the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002235674
Device count
3
DM exempt
false
Premarket exempt
true
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
00671504668302TravelJohn® ResealableTJ1N-C 66918C-EU366918C-EU32023-07-20
00671504669187TravelJohn® ResealableTJ1N-C 66918C66918C2023-07-20
00671504668296TravelJohn® Vomit/Urinal BagsTJ1P 66829B66829B2023-07-20
10671504668309TravelJohn® ResealableTJ1N-C 66918C-EU366918C-EU32023-07-20
00671504668500TravelJohn® ResealableTJ1N-C 66850C66850C2023-07-20
00671504668524TravelJane®TJ1R-C 66852C66852C2023-07-20
00671504668920TravelJohn®TJ1A-C 66892C66892C2023-07-20
00671504669002TravelJohn® Solid Waste BagsTJ2C 66900B66900B2023-07-20
00671504669118TravelJohn®TJ1A 66911669112023-07-20
00671504669125TravelJohn® Resealable DuoTJ1C-C 66912C66912C2023-07-20
00671504670039TravelJohn®TJ1A-C 67003670032023-07-20
00671504670428TravelJohn® ResealableTJ1N-C 67042670422023-07-20
00671504670466TravelJohn® ResealableTJ1N-C 67046670462023-07-20
00671504670633TravelJane® ResealableTJ1T-C 67063670632023-07-20
00671504700187TravelJohn® Resealable DuoTJ1C-C 70018C70018C2023-07-20
00685816000101Brief Relief®IBR608IBR6082023-07-20

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