FDA.report

VACUTRON

Primary DI
00260720005161
Brand
VACUTRON
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
MINI-VAC
Catalog number
22-13-1113-Y
Device description
CONTINUOUS SUCTION REGULATORS
Published
2016-09-14
Public version status
Update
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
00260720005161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720005161002607200051612607200051610260720005161

GMDN Terms

TermDefinition
Tracheal suction vacuum regulatorA device designed to connect to the vacuum terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure (vacuum) provided by the system and applied in the evacuation of fluids, mucus or solids from the trachea. The device is connected either directly or via dedicated vacuum tubing to the wall outlet and helps provide continuous or intermittent suction at variable levels. It is typically constructed of metal and plastic and includes a manometer for monitoring suction/vacuum pressure. It may include a disposable antibacterial filter, a collection bottle and a mechanical anti-overflow mechanism to help protect the device and the vacuum pipeline system.

Sterilization Methods

Method

Regulatory Flags

DUNS number
099674145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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