FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106353682
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOPMIKPGRA
Catalog number
SOPMIKPGRA
Device description
KNEE PACK
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJAIntravenous extension tubing set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106353682PackageGS12In Commercial Distribution
10197106353684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710635368250197106353682
1019710635368410197106353684

GMDN Terms#

Term, Definition table
TermDefinition
Decontamination floor mat, single-useA pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. The product is for single-use and is not washed or cleaned for reuse. It may be a pad of layered adhesive sheets that bind dirt touching the surface; when the sheet is sufficiently saturated it is peeled off and discarded to reveal a new adhesive surface.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450029364Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
10884450027339Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
20884450031234Merit Medical®Merit Medical Systems, Inc.OJA2026-03-19
20884450428188Merit Medical®Merit Medical Systems, Inc.OJA2026-03-14
10884450029203Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
10884450122560Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
20884450029668Merit Medical®Merit Medical Systems, Inc.OJA2026-03-12
20884450113688Merit Medical®Merit Medical Systems, Inc.OJA2026-03-10
20884450123458Merit Medical®Merit Medical Systems, Inc.OJA2026-03-04
20884450029262Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450428884Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450029807Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
10884450121778Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
20884450437340Merit Medical®Merit Medical Systems, Inc.OJA2026-02-19
10884450028169Merit Medical®Merit Medical Systems, Inc.OJA2026-02-18
10884450027384Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
20884450029019Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450121396Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450428631Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450434199Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450122287Merit Medical®Merit Medical Systems, Inc.OJA2026-02-06
10884450031183Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
20884450106260Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
10884450121969Merit Medical®Merit Medical Systems, Inc.OJA2026-02-03
20884450027183Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450136823Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450122024Merit Medical®Merit Medical Systems, Inc.OJA2026-01-28
10884450029272Merit Medical®Merit Medical Systems, Inc.OJA2026-01-27
20884450136809Merit Medical®Merit Medical Systems, Inc.OJA2026-01-24
10884450122034Merit Medical®Merit Medical Systems, Inc.OJA2026-01-23