FDA.reportPublic FDA data

AWI

Primary DI
06957277201583
Brand
AWI
Company
Apex (Guangzhou) Tools & Orthopedics Co.
Model
210-01
Catalog number
210-01
Device description
EXTREMITY IRRIGATION BAG
Published
2022-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
06957277201583PrimaryGS10
16957277201580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06957277201583069572772015836957277201583
1695727720158016957277201580

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Regulatory Flags#

DUNS number
529936792
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06957277203150iTool®KQ-07104NTKQ-07104NT2026-05-15
06957277203167iTool®KQ-14104NTKQ-14104NT2026-05-15
06957277203174iTool®KQ-09109NTKQ-09109NT2026-05-15
06957277203181iTool®KQ-09106NTKQ-09106NT2026-05-15
06957277203198iTool®KQ-11109NTKQ-11109NT2026-05-15
06957277203204iTool®KQ-16104NT KQ-16104NT 2026-05-15
06957277203211iTool®SQ-20109NTSQ-20109NT2026-05-15
06957277203228iTool®SQ-20609NTSQ-20609NT2026-05-15
06957277203235iTool®SQ-24109NTSQ-24109NT2026-05-15
06957277203242iTool®SQ-28109NTSQ-28109NT2026-05-15
06957277203112iTool®112-04112-042025-10-31
06957277203129iTool®112-02112-022025-10-31
06957277203136iTool®112-01112-012025-10-31
06957277202603AWI209-042024-03-06
06957277202610AWI209-062024-03-06
06957277202504AWI209-00-68209-00-682023-08-11
16957277200354AWI209-00-68209-00-682023-08-11
06957277201590AWI210-02210-022022-03-02
16957277201580AWI210-01210-012022-03-02
16957277201597AWI210-02210-022022-03-02

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