FDA.reportPublic FDA data

Sure Care

Primary DI
20884527022028
Brand
Sure Care
Company
Cardinal Health, Inc.
Model
1130A
Catalog number
1130A
Device description
Bladder Control Pads,Extra Heavy
Published
2018-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20884527022028PackageGS1168In Commercial Distribution
10884527022021PrimaryGS10
30884527022025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452702202820884527022028
1088452702202110884527022021
3088452702202530884527022025

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants linerA disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14.5Inch
Width4Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
42
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810065846433WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846440WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846457WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846464WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846471WeareverPRIME LIFE FIBERSEYQ2025-09-23
00810065846488WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010177WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010184WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010191WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010207WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010214WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010221WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010658WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010665WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010672WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010689WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010696WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010702WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010719WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010726WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010733WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877010740WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011501WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011518WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011525WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011532WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011549WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011556WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011563WeareverPRIME LIFE FIBERSEYQ2025-09-23
00813877011570WeareverPRIME LIFE FIBERSEYQ2025-09-23