DEVICE: Welch Allyn, Inc. (00732094335439)

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Device Record History
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Device Identifier (DI) Information
Welch Allyn, Inc.
901058
In Commercial Distribution
74RE
WELCH ALLYN, INC.
00732094335439
GS1

1
198227881 *Terms of Use
WFR CSM NIBP Mas RRp Braun Pro6000
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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?
57962 Prostate electrolytic therapy system
A mobile assembly of mains electricity (AC-powered) devices designed to treat benign prostatic hyperplasia (BPH) and prostatitis through transurethral electrochemical treatment causing liquefaction necrosis to the diseased peri-urethral prostate. It typically consists of a power supply that provides a low output level (e.g., less than 30 volts) and an adjustable output current [e.g., 0 to 100 milliampere (mA)], operator's console, monitoring systems, alarms, software, and an electrolytic therapeutic catheter.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MWI Monitor, physiological, patient (without arrhythmia detection or alarms)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b84d5dde-8e51-4a2d-834c-5b2506fbd338
September 02, 2021
1
August 25, 2021
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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
00732094335781 1 00732094335439 In Commercial Distribution
00732094335828 1 00732094335439 In Commercial Distribution
00732094335798 1 00732094335439 In Commercial Distribution
00732094335804 1 00732094335439 In Commercial Distribution
00732094335811 1 00732094335439 In Commercial Distribution
00732094335774 1 00732094335439 In Commercial Distribution
00732094335767 1 00732094335439 In Commercial Distribution
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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

[?]
+1(315)685-2834
GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
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