FDA.reportPublic FDA data

Medline

Primary DI
10888277101555
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND12582
Catalog number
DYND12582
Device description
STRAPS, LEG BAG, ELASTIC, HOOK&LOOP, PR
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30888277101559PackageGS120In Commercial Distribution
10888277101555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088827710155930888277101559
1088827710155510888277101555

GMDN Terms#

Term, Definition table
TermDefinition
Open-ended wearable urine collection bag, non-sterileA non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Label does not mention Storage Conditions

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10860012266811Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
00618125191185TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
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00615521020019ALLENHILL-ROM, INC.NNW2023-05-26
00615521020606ALLENHILL-ROM, INC.NNW2023-05-26
00615521020675ALLENHILL-ROM, INC.NNW2023-05-26
05708932135184ConveenColoplast A/SNNW2023-01-17
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10810087350489CoulmedCoulmed Products Group LLCNNW2023-01-06
10810087350502CoulmedCoulmed Products Group LLCNNW2023-01-06
00762123032282ColoplastColoplast A/SNNW2022-12-05
00762123032299ColoplastColoplast A/SNNW2022-12-05
05708932640312ConveenColoplast A/SNNW2022-12-02
05708932732420Conveen StandardColoplast A/SNNW2022-12-02
05708932640329ConveenColoplast A/SNNW2022-12-02
00762123002094Conveen StandardColoplast A/SNNW2022-12-02
00610075093427HollisterHOLLISTER INCORPORATEDNNW2022-12-01
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