DEVICE: DOPPLEX (05051968013941)

Device Identifier (DI) Information

DOPPLEX
ACC56
In Commercial Distribution
ACC56
HUNTLEIGH HEALTHCARE LIMITED
05051968013941
GS1

1
217207083 *Terms of Use
BOX,PPG ADHESIVE PAD - 500 OFF
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Basic adhesive tape A non-sterile, long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
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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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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

ce604f19-5da2-4a46-a3c6-7918517ebba0
March 29, 2018
2
September 19, 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
No
No
No
No CLOSE

Customer Contact

[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
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