DEVICE: Mediplus (05055140701633)

Device Identifier (DI) Information

Mediplus
3651
In Commercial Distribution

MEDIPLUS LTD
05055140701633
GS1

1
228480810 *Terms of Use
38mm penile cuff 1m lead
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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
Male urinary outflow analysis system cuff A non-sterile inflatable cuff that is a component of a male urinary outflow analysis system. It is intended to be attached around the penis and inflated/deflated according to a software program while the patient is urinating to provide data that can be used to help diagnose lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) in men. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FEN DEVICE, CYSTOMETRIC, HYDRAULIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
Width: 38.0 Millimeter
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Device Record Status

609ae480-eb0a-48b4-bd66-1c113bdbe0f4
March 29, 2018
2
September 16, 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
15055140701630 25 05055140701633 In Commercial Distribution
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4401494551200
help@mediplus.co.uk
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