FDA.reportPublic FDA data

MABIS DMI

Primary DI
10767056075174
Brand
MABIS DMI
Company
D-M-S HOLDINGS, INC.
Model
D 7517
Catalog number
D 7517
Device description
U-BAG 24HR STERILE STANDARD ADHESIVE NEWBORN
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10767056075174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1076705607517410767056075174

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive infant/paediatric urine collection bag, open-endedA flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/paediatric patient. It is designed with an opening for urine drainage and is typically used for urine output measurement. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062028220
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

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
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
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