DEVICE: Bovie (10607151011540)

Device Identifier (DI) Information

Bovie
AD-330R-A2W
In Commercial Distribution
AD-330R-A2W
BOVIE MEDICAL CORPORATION
10607151011540
GS1

1
079940465 *Terms of Use
ACUDOP II 330R, NON-DISPLAY RECHARGEABLE UNIT WITH 2MHZ OB WATERPROOF PROBE
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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?
34040 Foetal Doppler system
A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
LXE Doppler, Fetal, Ultrasound
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090465 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

2ccb2f70-0d00-4756-9f3e-7c97b4b1f99b
July 06, 2018
3
March 30, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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