FDA.reportPublic FDA data

Zorro-Flow Inc.

Primary DI
10850049673096
Brand
Zorro-Flow Inc.
Company
ZORROFLOW LLC
Model
ZF-F-XS Assembly
Catalog number
ZF-F-XS
Device description
Zorro-Flow Extra-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
OTC
false
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
10850049673096PackageGS16In Commercial Distribution
20850049673093PackageGS112In Commercial Distribution
00850049673099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004967309610850049673096
2085004967309320850049673093
00850049673099008500496730998500496730990850049673099

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
Weight2.5Kilogram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111226728
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850049673082Zorro-Flow Inc.ZF-F-S AssemblyZF-F-S2024-11-01
00850049673099Zorro-Flow Inc.ZF-F-XS AssemblyZF-F-XS2024-11-01
10850049673089Zorro-Flow Inc.ZF-F-S AssemblyZF-F-S2024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850049673082Zorro-Flow Inc.ZORROFLOW LLCFOC2024-11-01
00850049673099Zorro-Flow Inc.ZORROFLOW LLCFOC2024-11-01
10850049673089Zorro-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