FDA.reportPublic FDA data

Abena

Primary DI
05703538501616
Brand
Abena
Company
Abena North America, Inc
Model
1000025232
Device description
Delta Slip M1, premium holds 1700ml, hip sizes for 27.56- 43.31''
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05703538501623PackageGS14In Commercial Distribution
05703538501616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05703538501623057035385016235703538501623
05703538501616057035385016165703538501616

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store dry, room temperature and no direct sunlight

Contacts#

Phone, Email table
PhoneEmail
844-223-6248info-na@abena.com

Regulatory Flags#

DUNS number
078740398
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
05713571001103Abena10000213342023-06-12
05713571010792Abena10000310562026-03-30
05713571010815Abena10000310572026-03-30
05703538498732Abena10000251072026-02-18
05703538498794Abena10000251102026-02-18
05703538498855Abena10000251132026-02-18
05703538498879Abena10000251142026-02-18
05703538498749Abena10000251072026-02-18
05703538498800Abena10000251102026-02-18
05703538498862Abena10000251132026-02-18
05703538498886Abena10000251142026-02-18
05703538382246Abena171622020-03-05
05703538330254Abena92562020-03-05
05703538357176Abena15562020-03-05
00190509001032Abena19572020-04-02
00190509001049Abena19582020-04-02
00190509001056Abena19592020-04-02
00190509001315Abena19602020-05-29
00190509001322Abena19612020-05-29
00190509001339Abena19622020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441224SuresVIVE HEALTH LLCEYQ2026-07-21
00810226441231SuresVIVE HEALTH LLCEYQ2026-07-21
00810226441248SuresVIVE HEALTH LLCEYQ2026-07-21
00810178889334SuresVIVE HEALTH LLCEYQ2026-07-17
00810178889341SuresVIVE HEALTH LLCEYQ2026-07-17
00810178889358SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441156SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441163SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441170SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441187SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441194SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441200SuresVIVE HEALTH LLCEYQ2026-07-17
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.EYQ2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15