FDA.report

O2 VECTOR 6 16x17x2.5"

Primary DI
08717261042947
Brand
O2 VECTOR 6 16x17x2.5"
Company
Vicair B.V.
Model
OVR6/4043
Device description
Wheelchair cushion
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717261042947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717261042947087172610429478717261042947

GMDN Terms

TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Device Sizes

TypeValueUnit
Depth17Inch
Device Size Text, specify0
Width16Inch

Sterilization Methods

Method

Regulatory Flags

DUNS number
416605657
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08717261074016Vicair 4 ZV 18x18x3.25"FZV/45452025-12-03
08717261040882O2 ADJUSTER 10 OAD10/SPECIAL SIZE2023-12-14
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08717261040912O2 ADJUSTER 10 14x16x4"OAD10/35402023-12-14
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08717261040936O2 ADJUSTER 10 14x18x4"OAD10/35452023-12-14
08717261040943O2 ADJUSTER 10 15x14x4"OAD10/38352023-12-14
08717261040950O2 ADJUSTER 10 15x15x4"OAD10/38382023-12-14
08717261040967O2 ADJUSTER 10 15x16x4"OAD10/38402023-12-14
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08717261041001O2 ADJUSTER 10 16x14x4"OAD10/40352023-12-14
08717261041018O2 ADJUSTER 10 16x15x4"OAD10/40382023-12-14
08717261041025O2 ADJUSTER 10 16x16x4"OAD10/40402023-12-14
08717261041032O2 ADJUSTER 10 16x17x4"OAD10/40432023-12-14
08717261041049O2 ADJUSTER 10 16x18x4"OAD10/40452023-12-14
08717261041056O2 ADJUSTER 10 16x19x4"OAD10/40482023-12-14
08717261041063O2 ADJUSTER 10 16x20x4"OAD10/40502023-12-14

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