FDA.reportPublic FDA data

RECEPTAL™ TANDEM LONG 3L CANISTERS SUPPORT

Primary DI
40704411001127
Brand
RECEPTAL™ TANDEM LONG 3L CANISTERS SUPPORT
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
434390401
Device description
RECEPTAL™ TANDEM LONG 3L CANISTERS SUPPORT
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411001127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100112740704411001127

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, vacuumAn assembly of devices designed to evacuate fluid, tissue, gas, or foreign materials from a body cavity or lumen by means of suction. It is connected via dedicated vacuum tubing to the vacuum terminal unit (wall outlet) of a vacuum pipeline system and powered via a hospital's central vacuum system. It generally includes a regulator, tubing, an overflow trap, plastic/glass collection container(s), a suction tip, and possibly moisture/microbial filters. The regulator controls the vacuum in the suction tubing for the removal of materials into the collection container. This system can be used in a wide variety of hospital settings, but is limited to connection to a central vacuum system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
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