FDA.reportPublic FDA data

Eakin

Primary DI
80768455126855
Brand
Eakin
Company
T.G. EAKIN LIMITED
Model
839280
Device description
Eakin access window
Published
2023-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FONBag, Drainage, With Adhesive, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455126859PrimaryGS10
80768455126855Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455126859007684551268597684551268590768455126859
8076845512685580768455126855

GMDN Terms#

Term, Definition table
TermDefinition
Wound drainage bagA plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442891871000mail@eakin.co.uk

Regulatory Flags#

DUNS number
229282421
Device count
5
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
true
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
15056276805513Eakin8390072026-02-03
15056276819060Eakin8390082026-02-03
15056276819084Eakin8390272026-02-03
15056276819091Eakin8390282026-02-03
05056276805516Eakin8390072026-02-03
05056276819063Eakin8390082026-02-03
05056276819087Eakin8390272026-02-03
05056276819094Eakin8390282026-02-03
00768455108725Eakin8390012023-05-16
00768455108732Eakin8390022023-05-16
00768455109333Eakin8390032023-05-16
00768455109340Eakin8390042023-05-16
00768455118250Eakin8390052023-05-16
00768455126798Eakin8392532023-05-16
00768455126804Eakin8392632023-05-16
00768455126811Eakin8392652023-05-16
00768455126828Eakin8392642023-05-16
00768455126835Eakin8392672023-05-16
00768455126842Eakin8392682023-05-16
00768455126859Eakin8392802023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B674WIKB1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB1402101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB2001101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
00768455126798EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126804EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126811EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126828EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126835EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126842EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126859EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126866EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126873EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126880EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126897EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126903EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126910EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126927EakinT.G. EAKIN LIMITEDFON2023-05-16
16937359412394MaidwocWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2023-04-19
16937359412387Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-21
16937359412370SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-15
16937359412356SteadliveWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-07
00768455105670NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111916ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111985ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111992ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455112036ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114818ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29