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
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957391Create BiotechCREATE BIOTECH CO., LTD.NNW2026-07-21
00860012266807Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10860012266811Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
00618125191185TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
15060797553860NADavid Scott CompanyNNW2023-07-26
00615521015336ALLENHILL-ROM, INC.NNW2023-05-26
00615521015350ALLENHILL-ROM, INC.NNW2023-05-26
00615521015367ALLENHILL-ROM, INC.NNW2023-05-26
00615521019990ALLENHILL-ROM, INC.NNW2023-05-26
00615521020002ALLENHILL-ROM, INC.NNW2023-05-26
00615521020019ALLENHILL-ROM, INC.NNW2023-05-26
00615521020606ALLENHILL-ROM, INC.NNW2023-05-26
00615521020675ALLENHILL-ROM, INC.NNW2023-05-26
05708932135184ConveenColoplast A/SNNW2023-01-17
00762123017197ConveenColoplast A/SNNW2023-01-17
15060797553600NADavid Scott CompanyNNW2023-01-09
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
00610075093434HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093489HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093496HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093421HollisterHOLLISTER INCORPORATEDNNW2022-12-01