Sure Care

Primary DI
50192253002001
Brand
Sure Care
Company
Cardinal Health 200, LLC
Model
1560P
Catalog number
1560P
Device description
Sure Care Plus Select Heavy Absorbency
Published
2021-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EYQGARMENT, PROTECTIVE, FOR INCONTINENCE

Product Code Classifications

CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253002001PackageGS14In Commercial Distribution
00192253002006PrimaryGS10
10192253002003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5019225300200150192253002001
00192253002006001922530020061922530020060192253002006
1019225300200310192253002003

GMDN Terms

TermDefinition
Incontinence pants, single-useAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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