AccessGUDID - DEVICE: Mediplus (05055140701633)

GUDID

Device Identifier (DI) Information

Brand Name: Mediplus
Version or Model: 3651
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIPLUS LTD

Primary DI Number: 05055140701633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 228480810 *Terms of Use

Device Description: 38mm penile cuff 1m lead

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58265	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 38.0 Millimeter

Device Record Status

Public Device Record Key: 609ae480-eb0a-48b4-bd66-1c113bdbe0f4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4401494551200
Email: help@mediplus.co.uk

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