FDA.reportPublic FDA data

Blueline

Primary DI
00199536911123
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
676108
Device description
"Fuff/Polymer Underpad, Heavy Absorbency, 30""x36"""
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30199536911124PackageGS110In Commercial Distribution
50199536911128PackageGS15In Commercial Distribution
00199536911123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019953691112430199536911124
5019953691112850199536911128
00199536911123001995369111231995369111230199536911123

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Regulatory Flags#

DUNS number
119522714
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199536902008Blueline2802T2026-05-15
00199536902015Blueline2803T2026-05-15
00199536902022Blueline2804T2026-05-15
00199536902039Blueline2805T2026-05-15
00199536902046Blueline2806T2026-05-15
00199536902053Blueline2807T2026-05-15
00199536902107Blueline2842P2026-05-15
00199536902114Blueline2843P2026-05-15
00199536902121Blueline2844P2026-05-15
00199536902138Blueline2845P2026-05-15
00199536902145Blueline2846P2026-05-15
00199536902152Blueline2847P2026-05-15
00199536902206Blueline2812T2026-05-15
00199536902213Blueline2813T2026-05-15
00199536902220Blueline2814T2026-05-15
00199536902237Blueline2815T2026-05-15
00199536902244Blueline2816T2026-05-15
00199536902251Blueline2817T2026-05-15
00199536902305Blueline2852P2026-05-15
00199536902312Blueline2853P2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330704813ProCureTwin Med, LLCEYQ2026-04-28
10840330704820ProCureTwin Med, LLCEYQ2026-04-28
10840330704837ProCureTwin Med, LLCEYQ2026-04-28
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
10603354120669ComfortTopEHOB INCKME2025-01-22
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09
10197106613504CARDINAL HEALTHCardinal Health 200, LLCKME2024-04-23
07613327632873Sage TAP LCSAGE PRODUCTS, LLCKME2024-03-26
07613327632880Sage TAP LCSAGE PRODUCTS, LLCKME2024-03-26
M20810063642CUSTOMEDCUSTOMED INCKME2023-08-10
M20890029842CUSTOMEDCUSTOMED INCEYQ2023-08-10
M20890029852CUSTOMEDCUSTOMED INCEYQ2023-08-10
M20890029862CUSTOMEDCUSTOMED INCEYQ2023-08-10
M20890029872CUSTOMEDCUSTOMED INCEYQ2023-08-10
M20890029882CUSTOMEDCUSTOMED INCEYQ2023-08-10
M20890030922CUSTOMEDCUSTOMED INCKME2023-08-10
M20890030932CUSTOMEDCUSTOMED INCKME2023-08-10
M20890031442CUSTOMEDCUSTOMED INCKME2023-08-10
M20890040522CUSTOMEDCUSTOMED INCKME2023-08-10
10850044799852SURGYCOSurgyco LLCKME2023-06-30
10850044799869SURGYCOSurgyco LLCKME2023-06-30