FDA.reportPublic FDA data

Kendall

Primary DI
00884521168674
Brand
Kendall
Company
Cardinal Health, Inc.
Model
MKN34854
Catalog number
MKN34854
Device description
Fluff Underpad,X-Large,Moderate
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBEDDING, DISPOSABLE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521168678PackageGS1120In Commercial Distribution
00884521168674PrimaryGS10
00884521535995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088452116867820884521168678
00884521168674008845211686748845211686740884521168674
00884521535995008845215359958845215359950884521535995

GMDN Terms#

Term, Definition table
TermDefinition
Cottonoid padA cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Inch
Width23Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
20
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521022171SharpSafety878187812016-09-24
30884521019298SharpSafety8836SA8836SA2016-09-24
30884521022816Monoject898989892016-09-24
40884521022752Monoject893489342016-09-24
40884521022899Monoject8985S8985S2016-09-24
10884527019649Argyle888830160688883016062016-09-24
10884527019700Argyle888830171388883017132016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884521012301Monoject118030077711803007772016-09-24
10884521018266Monoject897089702016-09-24
10884521022782SharpSafety8512018512012016-09-24
10884521023253Monoject8506SA8506SA2016-09-24
10884521023369Monoject85221R85221R2016-09-24
10884521023482SharpSafety8534SA8534SA2016-09-24
10884521050310Argyle888856080588885608052016-10-06
10884521050747Argyle888856101988885610192016-09-24
10884521050754Argyle888856102788885610272016-09-24
10884521050761Argyle888856103588885610352016-09-24
10884521050778Argyle888856104388885610432016-09-24
10884521050785Argyle888856105088885610502016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
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
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
M68959120030Hypothermia Management SetSafeguard US Operating, LLCKME2025-10-24
00199536911048BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911055BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911062BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911000BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911017BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911024BluelineTransparent Supply Solutions Ltd.KME2025-09-22
00199536911031BluelineTransparent Supply Solutions Ltd.KME2025-09-22
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03