FDA.reportPublic FDA data

VacFix Pump

Primary DI
B790VFPUMP0
Brand
VacFix Pump
Company
TALON
Model
VF-PUMP
Catalog number
VF-PUMP
Device description
The VacFix Pump is a device used to remove air from vacuum fixation cushions.
Published
2019-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWYHolder, Head, Radiographic
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895697000VAC FIX(R) SYSTEMS&S Par Scientific1990-01-12IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B790VFPUMP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-mould patient positioning systemAn assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS).

Contacts#

Phone, Email table
PhoneEmail
2818151300info@taloncontrols.com

Regulatory Flags#

DUNS number
005574330
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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