FDA.report

Urinary Leg Bag

Primary DI
00616784428123
Brand
Urinary Leg Bag
Company
DYNAREX CORPORATION
Model
4281
Device description
Urinary Leg Bag, Medium, 600mL, with Anti-Reflux Valve, Sterile Fluid Pathway
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784428123PackageGS112In Commercial Distribution
00616784428130PackageGS14In Commercial Distribution
00616784428116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784428123006167844281236167844281230616784428123
00616784428130006167844281306167844281300616784428130
00616784428116006167844281166167844281160616784428116

GMDN Terms

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

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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50192253028469DoverCardinal Health 200, LLCKNX2024-12-20
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50192253028551DoverCardinal Health 200, LLCKNX2024-12-20
50192253027936DoverCardinal Health 200, LLCKNX2024-11-04
50192253028285DoverCardinal Health 200, LLCKNX2024-11-04
50192253028490DoverCardinal Health 200, LLCKNX2024-11-04
50192253031445DoverCardinal Health 200, LLCKNX2024-11-04