FDA.report

MediChoice® Suction Canister Filter

Primary DI
40704411005996
Brand
MediChoice® Suction Canister Filter
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
WFM01FLT
Device description
MediChoice® Suction Canister Filter Reusable External Shut-Off Valve 1 Each
Published
2019-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30704411005999PackageGS110In Commercial Distribution
40704411005996PackageGS110In Commercial Distribution
10704411005995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070441100599930704411005999
4070441100599640704411005996
1070441100599510704411005995

GMDN Terms

TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
825673239
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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