FDA.reportPublic FDA data

Kroger

Primary DI
00041260377501
Brand
Kroger
Company
KROGER CO., THE
Model
041260377501
Device description
Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm). Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Published
2020-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041260377508PackageGS172Not in Commercial Distribution
00041260377501PrimaryGS10
60041260377503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004126037750810041260377508
00041260377501000412603775010412603775010041260377501
6004126037750360041260377503

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8006326900xx@xx.xx

Regulatory Flags#

DUNS number
006999528
Device count
8
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041260025747Kroger04126002574763610912025-08-05
00041260011658Kroger PJ Masks0412600116582021-01-13
00041260017957Kroger0412600179572023-01-31
00041260017964Kroger0412600179642023-01-31
00041260377518Kroger0412603775182019-10-30
00041260383809Kroger0412603838092020-06-22
00041260383816Kroger0412603838162020-06-22
00041260026850Kroger0412600268502026-03-09
60041260026852Kroger0412600268502026-03-09
60041260025749Kroger04126002574763610912025-08-05
10041260346962Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260346979Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260360685Kroger Premium Blood Glucose Meter8000-067682016-09-24
10041260360692Kroger Premium Blood Glucose Test Strips8000-067622016-09-24
00011110338235Kroger Pen Needles7000013332016-09-24
00041260003592Kroger Pen Needles7000147202019-06-01
00041260003608Kroger Pen Needles7000147212019-06-01
00041260343469Kroger Pen Needles7000013322016-09-24
00041260364624Kroger Pen Needles7000013312016-09-24
20011110338239Kroger Pen Needles7000013332016-09-24

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