FDA.reportPublic FDA data

Zorro-Flow Inc.

Primary DI
00850049673082
Brand
Zorro-Flow Inc.
Company
ZORROFLOW LLC
Model
ZF-F-S Assembly
Catalog number
ZF-F-S
Device description
Zorro-Flow Small Female Urine Collection System, Assembly of 1 unit
Published
2024-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FOCBag, Urine Collection, Newborn

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOCBag, Urine Collection, NewbornGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850049673089PackageGS16In Commercial Distribution
20850049673086PackageGS112In Commercial Distribution
00850049673082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004967308910850049673089
2085004967308620850049673086
00850049673082008500496730828500496730820850049673082

GMDN Terms#

Term, Definition table
TermDefinition
Wearable adult urine collection bag, closed-endedA flexible plastic pouch designed to connect to a urinary catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is not designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility and is disposed of when full. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight6Kilogram

Regulatory Flags#

DUNS number
111226728
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049673099Zorro-Flow Inc.ZF-F-XS AssemblyZF-F-XS2024-11-01
10850049673089Zorro-Flow Inc.ZF-F-S AssemblyZF-F-S2024-11-01
10850049673096Zorro-Flow Inc.ZF-F-XS AssemblyZF-F-XS2024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049673099Zorro-Flow Inc.ZORROFLOW LLCFOC2024-11-01
10850049673089Zorro-Flow Inc.ZORROFLOW LLCFOC2024-11-01
10850049673096Zorro-Flow Inc.ZORROFLOW LLCFOC2024-11-01
10767056075013MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075051MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075112MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075136MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075150MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075174MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075211MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075259MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075310MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075334MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075358MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075372MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23
10767056075402MABIS DMID-M-S HOLDINGS, INC.FOC2016-09-23