AccessGUDID - DEVICE: Mediplus (05055140702814)

GUDID

Device Identifier (DI) Information

Brand Name: Mediplus
Version or Model: 2309
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIPLUS LTD

Primary DI Number: 05055140702814
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 228480810 *Terms of Use

Device Description: Anorectal response catheter, 14Fr

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?
17745	Gastrointestinal motility manometric catheter, non-electronic	A non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLA	MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031617	000

Device Exempt from Premarket Submission: No 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
Catheter Gauge: 14.0 French

Device Record Status

Public Device Record Key: 45ec177e-1e58-41f2-b3e3-a49d148aa0c6
Public Version Date: August 05, 2022
Public Version Number: 4
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
15055140702811	10	05055140702814		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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES