FDA.reportPublic FDA data

Disposable Urinary Leg Bag

Primary DI
16974500612562
Brand
Disposable Urinary Leg Bag
Company
GCMEDICA ENTERPRISE LTD.(WUXI)
Model
JH02B02
Device description
700 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
Published
2025-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAQBag, Urine Collection, Leg, For External Use, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974500612562PackageGS148In Commercial Distribution
06974500612565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697450061256216974500612562
06974500612565069745006125656974500612565

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, closed-endedA flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from an adult/adolescent patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560122957
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974500612718Rigid Uterine Aspiration CuretteGC7049A07AU012026-05-18
06974500612725Rigid Uterine Aspiration CuretteGC7049A08AU012026-05-18
06974500612732Rigid Uterine Aspiration CuretteGC7049A09AU012026-05-18
06974500612749Rigid Uterine Aspiration CuretteGC7049A10AU012026-05-18
06974500612756Rigid Uterine Aspiration CuretteGC7049A11AU012026-05-18
06974500612763Rigid Uterine Aspiration CuretteGC7049A12AU012026-05-18
06974500612770Rigid Uterine Aspiration CuretteGC7049A14AU012026-05-18
06974500612787Rigid Uterine Aspiration CuretteGC7049A16AU012026-05-18
06974500612794Rigid Uterine Aspiration CuretteGC7049D14AU012026-05-18
06974500612824Rigid Uterine Aspiration CuretteGC7049B07BU012026-05-18
06974500612831Rigid Uterine Aspiration CuretteGC7049B08BU012026-05-18
06974500612848Rigid Uterine Aspiration CuretteGC7049B09BU012026-05-18
06974500612855Rigid Uterine Aspiration CuretteGC7049B10BU012026-05-18
06974500612862Rigid Uterine Aspiration CuretteGC7049B11BU012026-05-18
06974500612879Rigid Uterine Aspiration CuretteGC7049B12BU012026-05-18
06974500612886Rigid Uterine Aspiration CuretteGC7049B14BU012026-05-18
06974500612893Rigid Uterine Aspiration CuretteGC7049B16BU012026-05-18
06974500612909Rigid Uterine Aspiration CuretteGC7049E14BU012026-05-18
06974500613333Flexible Uterine Aspiration CuretteGC7049C04AU012026-05-18
06974500613340Flexible Uterine Aspiration CuretteGC7049C05AU012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046961018612ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
04046961018650ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
00850063139496Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139502Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139519Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139526Neil Medical Group Neil Medical GroupFAQ2025-12-08
06975424198265Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198289Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198302Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198326Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198340Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198364Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06975424198388Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198269Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198283Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198306Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198320Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198344Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198368Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198382Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
06974500612558Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612565Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
06974500612572Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612555Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612579Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
00661392002241LSL HEALTHCARELSL Industries, LLCFAQ2025-05-16
10661392002248LSL HEALTHCARELSL Industries, LLCFAQ2025-05-16
00810113579764ViveVIVE HEALTH LLCFAQ2025-04-07
00810113579979ViveVIVE HEALTH LLCFAQ2025-04-07
00810113579986ViveVIVE HEALTH LLCFAQ2025-04-07