FDA.report

VACUTRON

Primary DI
00260720009060
Brand
VACUTRON
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
MINI-VAC
Catalog number
22-16-1106-G
Device description
INTERMITTENT SUCTION REGULATORS
Published
2016-09-09
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
KDPRegulator, Vacuum

Product Code Classifications

CodeDeviceSpecialtyClass
KDPRegulator, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00260720009060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720009060002607200090602607200090600260720009060

GMDN Terms

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

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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