FDA.report

VACUTRON

Primary DI
00260720006571
Brand
VACUTRON
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
MINI-VAC
Catalog number
22-14-1200
Device description
HIGH VACUUM SUCTION REGULATORS
Published
2016-09-12
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
00260720006571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720006571002607200065712607200065710260720006571

GMDN Terms

TermDefinition
Neurosurgical suction regulatorA device designed to be attached to a suction system to control the degree of negative pressure (suction) applied in the evacuation of fluids, solids, or gases from the body during a neurosurgical procedure where the precise level of suction can be critical, e.g., during cranial surgery. The device is typically mounted onto the suction system and is connected with tubing between the suction system's pump and the collection container; it has two or more pre-set levels that are selected by the operator (the surgeon) using a foot-switch.

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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