FDA.reportPublic FDA data

Neil Medical Group

Primary DI
00850063139526
Brand
Neil Medical Group
Company
Neil Medical Group
Model
4012
Device description
UNRINARY DRAIN BAG ANTIFEFLUX VALVE
Published
2025-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850063139526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063139526008500631395268500631395260850063139526

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122260045
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063139168NEIL MEDICALN100N1002024-08-07
00850063139175NEIL MEDICALN101N1012024-08-07
00850063139182NEIL MEDICALN102N1022024-08-07
00850063139373Neil Medical Group 2001-30ML2025-12-08
00850063139366Neil Medical Group 2001-10ML2025-12-08
00850063139434Neil Medical Group 20122025-12-08
00850063139441Neil Medical Group 20522025-12-08
00850063139458Neil Medical Group 20712025-12-08
00850063139465Neil Medical Group 20612025-12-08
00850063139199NEIL MEDICALN103N1032024-08-07
00850063139519Neil Medical Group 40132025-12-08
00850063139380Neil Medical Group 2004RED2025-12-08
00850063139397Neil Medical Group 2004PVC2025-12-08
00850063139403Neil Medical Group 2005-16FR2025-12-08
00850063139410Neil Medical Group 2005-18FR2025-12-08
00850063139427Neil Medical Group 2005-14FR2025-12-08
00850063139472Neil Medical Group 10012025-12-08
00850063139489Neil Medical Group 3002025-12-08
00850063139496Neil Medical Group 4024-1000ML2025-12-08
00850063139502Neil Medical Group 4024-500ML2025-12-08

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
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
16974500612562Disposable 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