DEVICE: BiDop 7 probe (00894912002692)

Device Identifier (DI) Information

BiDop 7 probe
PG-30
In Commercial Distribution
PG-30
KOVEN TECHNOLOGY, INC.
00894912002692
GS1

1
069261402 *Terms of Use
PPG Probe for Bidop 7
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
62331 Plethysmography phototransducer
A photoelectric sensor designed to be applied externally to a body area (e.g., limb, fingertip, toe, sacral region) for the transcutaneous measurement of blood volume changes using light detection. It is intended to be connected to a parent device (e.g., limb plethysmograph, pressure ulcer risk assessment analyser) whereby volume changes are displayed graphically to represent blood flow/pulse, typically for vascular function assessment in a limb [e.g., measurement of toe brachial pressure index], or to assess a patient’s risk of developing pressure ulcers. Although similar to a pulse oximeter probe it is not capable of oxygen saturation measurements. This is a reusable device.
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 [?]
K201114 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
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

7087b577-e89d-4af0-90dc-39bfb05a6f58
April 04, 2023
2
January 20, 2021
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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
Yes
No
No
No CLOSE

Customer Contact

[?]
314-542-2101
info@koven.com
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