FDA.reportPublic FDA data

Blueline

Primary DI
00199536911161
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
3771
Device description
Premium Quilted Ultra Underpad, Ultimate Absorbency, 40"x59"
Published
2026-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
30199536911162PackageGS15In Commercial Distribution
50199536911166PackageGS15In Commercial Distribution
00199536911161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019953691116230199536911162
5019953691116650199536911166
00199536911161001995369111611995369111610199536911161

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.

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699Support@gotss.com

Regulatory Flags#

DUNS number
119522714
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199536930407Blueline75112026-06-05
00199536930414Blueline75122026-06-05
00199536930421Blueline75132026-06-05
00199536930506Blueline75802026-06-05
00199536930513Blueline75812026-06-05
00199536910003Blueline76002026-05-15
00199536910010Blueline76012026-05-15
00199536910027Blueline76022026-05-15
00199536910034Blueline76032026-05-15
00199536910041Blueline76042026-05-15
00199536910058Blueline76052026-05-15
00199536910065Blueline76062026-05-15
00199536910072Blueline76072026-05-15
00199536910089Blueline76082026-05-15
00199536910096Blueline76202026-05-15
00199536910102Blueline76212026-05-15
00199536910119Blueline76222026-05-15
00199536910126Blueline76232026-05-15
00199536911109Blueline6761012026-05-15
00199536911116Blueline6761052026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536910003BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910010BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910027BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910034BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910041BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910058BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910065BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910072BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910089BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910096BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910102BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910119BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910126BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911109BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
10840330704813ProCureTwin Med, LLCEYQ2026-04-28
10840330704820ProCureTwin Med, LLCEYQ2026-04-28