DEVICE: Welch Allyn, Inc. (04041346030555)

Device Identifier (DI) Information

Welch Allyn, Inc.
901050
In Commercial Distribution
ABPM-7100
WELCH ALLYN, INC.
04041346030555
GS1

1
198227881 *Terms of Use
ABPM-7100 Ambulatory Blood Pressure Monitor including Monitor Pouch, Adult Cuff, Adult Plus Cuff, USB Cable; 4 Alkaline AA Batteries (Software Not Included)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood pressure long-term ambulatory recorder An automated, battery-powered, device designed to be worn on a patient for 24-hour recording of their blood pressure. The patient is connected to and wears the device while he or she performs normal daily activities. The recorded measurements can be down-loaded to an analyser at a medical facility.
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FDA Product Code

[?]
Product Code Product Code Name
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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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

ab2f05ee-e4eb-47d2-b121-3642b8e092fe
March 29, 2018
2
September 21, 2016
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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

[?]
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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