DEVICE: CONFORMat Versatek (B970CCV20)

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Device Record History
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Device Identifier (DI) Information
CONFORMat Versatek
CONFORMat 2 VersaTek System
In Commercial Distribution
CCV2
Tekscan, Inc.
B970CCV20
HIBCC

1
178180246 *Terms of Use
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330E Sensors, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
43829 Body-surface pressure mapping system
An assembly of electronic devices intended to be used to measure the contact pressure between the body surface and a pressure-sensing pad to provide a map of compression forces during planning of/preparation for personal mobility device use or body support device use by a patient. Described as pressure mapping technology (PMT), it includes a sensor pad and a dedicated computer/software for data analysis, and is typically used to customize the shape of a wheelchair seating cushion to reduce the risk of pressure sore development.
Active false
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FDA Product Code

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Product Code Product Code Name
JFC System, Pressure Measurement, Intermittent
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
8c7737fb-dcbe-4a3f-b78e-b5b5b96dd679
November 19, 2020
2
November 03, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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