DEVICE: PF 105-3 Double-Sided Tape Strip (07332834000219)

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Device Record History
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Device Identifier (DI) Information
PF 105-3 Double-Sided Tape Strip
PF 105-3
In Commercial Distribution

Perimed AB
07332834000219
GS1

100
354765570 *Terms of Use
PF 105-3 Double-Sided Tape Strip (100 pcs)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
60451 Laser Doppler blood flowmeter
A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DPW Flowmeter, Blood, Cardiovascular
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K974285 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
7b6e6267-516c-4c1c-be56-a8c6cae72887
May 25, 2021
4
September 13, 2016
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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: 07332834000202 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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