FDA.report

VacQfix™

Primary DI
10841962110010
Brand
VacQfix™
Company
Qfix
Model
RT-4517-12075F35M
Catalog number
RT-4517-12075F35M
Device description
Vac-Q-Fix Cushion 120cm x 75cm, 35L Fill (Economy valve)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JAICouch, radiation therapy, powered

Product Code Classifications

CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841962110010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084196211001010841962110010

GMDN Terms

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).

Device Sizes

TypeValueUnit
Length120Centimeter
Total Volume35Liter
Width75Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(610)268-0585Compliance@qfix.com

Regulatory Flags

DUNS number
808875397
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
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00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
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00841962119887Opti-HandlesQfixJAI2025-07-09
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