FDA.reportPublic FDA data

Medline

Primary DI
10080196990320
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND12578
Catalog number
DYND12578
Device description
BAG,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30080196990324PackageGS112In Commercial Distribution
10080196990320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3008019699032430080196990324
1008019699032010080196990320

GMDN Terms#

Term, Definition table
TermDefinition
Wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent 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
No natural rubber latex
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
06941298160523RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161292RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161308RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161315RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
06941298161322RollmedHangzhou Rollmed Co.,ltd.FAQ2026-07-07
10192253071108DoverCardinal Health 200, LLCKNX2026-06-24
10192253071139DoverCardinal Health 200, LLCKNX2026-06-24
10192253071146DoverCardinal Health 200, LLCKNX2026-06-24
10192253068603DoverCardinal Health 200, LLCKNX2026-01-16
10192253068719DoverCardinal Health 200, LLCKNX2026-01-16
10192253068726DoverCardinal Health 200, LLCKNX2026-01-16
10192253068733DoverCardinal Health 200, LLCKNX2026-01-16
10192253067989DoverCardinal Health 200, LLCKNX2026-01-15
10192253068016DoverCardinal Health 200, LLCKNX2026-01-15
10192253068214DoverCardinal Health 200, LLCKNX2026-01-15
10840330701799ProCureTwin Med, LLCKNX2025-05-31
10840330701805ProCureTwin Med, LLCKNX2025-05-31
10192253028645DoverCardinal Health 200, LLCFAQ2025-04-04
10192253028652DoverCardinal Health 200, LLCFAQ2025-04-04
10192253028669DoverCardinal Health 200, LLCFAQ2025-04-04
10192253027792DoverCardinal Health 200, LLCKNX2025-04-01
10192253028232DoverCardinal Health 200, LLCKNX2025-04-01
10192253032161DoverCardinal Health 200, LLCKNX2025-04-01
10192253027945DoverCardinal Health 200, LLCKNX2025-03-20
10192253028461DoverCardinal Health 200, LLCKNX2024-12-20
10192253028522DoverCardinal Health 200, LLCKNX2024-12-20
10192253028539DoverCardinal Health 200, LLCKNX2024-12-20
10192253028546DoverCardinal Health 200, LLCKNX2024-12-20
10192253028560DoverCardinal Health 200, LLCKNX2024-12-20
10192253031126DoverCardinal Health 200, LLCKNX2024-12-20