FDA.reportPublic FDA data

Kendall

Primary DI
20884521177328
Brand
Kendall
Company
Cardinal Health, Inc.
Model
31312P
Catalog number
31312P
Device description
Abdominal Binder with 2-way Stretch,Medium
Published
2018-06-23
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
FSDBINDER, ABDOMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521177328PackageGS150In Commercial Distribution
10884521177321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117732820884521177328
1088452117732110884521177321

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, single-useA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width12Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
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
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975740361312MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361336MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361343MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361565MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361572MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361589MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361596MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361602MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361619MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361626MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361633MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361640MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361657MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361664MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361671MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361688MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361978MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361985MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361992MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362005MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362173MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362180MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362197MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362203MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
00190446660217PROCAREDJO, LLCFSD2025-05-14
00190446660279PROCAREDJO, LLCFSD2025-05-14
00190446660286PROCAREDJO, LLCFSD2025-05-14
00190446660293PROCAREDJO, LLCFSD2025-05-14
00190446660750PROCAREDJO, LLCFSD2025-05-14
00190446660767PROCAREDJO, LLCFSD2025-05-14