VacQfix™ RT-4517-100130PENF45M

GUDID 10841962118863

VacQfix Cushion, 100cm x 130cm, PEN, 45L fill

Qfix

Vacuum-mould patient positioning system

Primary Device ID	10841962118863
NIH Device Record Key	2f1519fd-3b06-47de-911e-f8949aeb847d
Commercial Distribution Status	In Commercial Distribution
Brand Name	VacQfix™
Version Model Number	RT-4517-100130PENF45M
Catalog Number	RT-4517-100130PENF45M
Company DUNS	808875397
Company Name	Qfix
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter
Width	100 Centimeter
Width	70 Centimeter
Length	130 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	45 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962118863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K060671

FDA Product Code

JAI	Couch, radiation therapy, powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-02-11
Device Publish Date	2022-02-03

On-Brand Devices [VacQfix™]

10841962111079	VacQfix Cushion, 96 X 55cm, 15L Fill
10841962111062	VacQfix Cushion, 96 X 55cm, 12L Fill
10841962119358	VacQfix Cushion 79cm x 93cm, 20L fill
10841962119341	VacQfix Cushion 79cm x 93cm, 20L fill
10841962119334	VacQfix Cushion, 65cm x 65cm, T-Shaped, 7L fill
10841962119327	VacQfix Cushion, 65cm x 65cm, T-Shaped , 7L fill
10841962119310	VacQfix Cushion, 96 X 55cm, 15L Fill
10841962119303	VacQfix Cushion, 96 x 55 cm, 15L Fill
10841962119297	VacQfix Cushion, 96 X 55cm, 12L Fill
10841962119280	VacQfix Cushion, 96 x 55 cm, 12L Fill
10841962119273	VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support
10841962119266	VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support
10841962119259	VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support
10841962119242	VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support
10841962119235	VacQFix Indexer
10841962119228	VacQfix Cushion, 150cm x 80cm, 65L fill
10841962119211	VacQfix Cushion, 150cm x 80cm, 65L fill
10841962119204	VacQfix Cushion, 70cm x 70cm, 20L fill
10841962119198	VacQfix Cushion, 70cm x 70cm, 20L fill
10841962119181	Vac Q-Fix Cushion 70 x 230 , 65L fill (Economy valve)
10841962119174	VacQfix Cushion 70 x 230 , 65L fill
10841962119167	VacQfix Cushion 70cm x 150cm 60L
10841962119150	VacQfix Cushion, 70cm x 150cm, 60L fill
10841962119143	Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II (Economy valve)
10841962119136	VacQfix Cushion, 120xm x 70cm, 40L Fill Gen.II
10841962119129	VacQfix Cushion, 50cm x 70cm, 15L fill
10841962119112	VacQfix Cushion, 50cm x 70cm, 15L fill
10841962119105	VacQfix Cushion, 40cm x 80cm, 15L fill
10841962119099	VacQfix Cushion, 40cm x 80cm, 15L fill
10841962119082	VacQfix Cushion 40cm x 80cm, 15L Fill
10841962119075	VacQfix Cushion, 40cm x 79cm, 15L fill
10841962119068	Vac-Q-Fix Cushion, 25cm x 35cm, 2.0L fill (Economy valve)
10841962119051	VacQfix Cushion, 25cm x 35cm, 2.0L fill
10841962119044	Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L fill (Economy valve)
10841962119037	VacQfix Cushion, 25cm x 35cm, 1.5L fill
10841962119020	VacQfix Cushion, 120/20cm x 230cm,90L fill
10841962119013	VacQfix Cushion, 120/80cm x 230cm, 90L fill
10841962119006	Vac-Q-Fix Cushion 120cm x 75cm, 35L Fill (Economy valve)
10841962118993	VacQfix Cushion 120cm x 75cm, 35L Fill
10841962118986	Vac-Q-Fix Cushion, 100cm x 70cm, 43L fill (Economy valve)
10841962118979	VacQfix Cushion, 100cm x 70cm, 43L fill
10841962118962	VacQfix Cushion, 100cm x 70cm, 40L fill
10841962118955	VacQfix Cushion, 100cm x 70cm, 40L fill
10841962118948	VacQfix Cushion, 100cm x70cm, 35 liter Fill
10841962118931	VacQfix Cushion, 100 cm x 70 cm 35 liter Fill
10841962118924	VacQfix Cushion, 100cm x 70cm, 30L fill
10841962118917	VacQfix Cushion, 100cm x 70cm, 30L fill
10841962118900	VacQfix Cushion, 100cm x 220cm, 120L fill
10841962118894	VacQfix Cushion, 100cm x 220cm, 120L fill
10841962118887	VacQfix Cushion, 100cm x 150cm, 70L fill