AccessGUDID - DEVICE: THD PressKit (08033737711293)

GUDID

Device Identifier (DI) Information

Brand Name: THD PressKit
Version or Model: THD PressKit (TR ENV)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800145
Company Name: THD SPA

Primary DI Number: 08033737711293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338430324 *Terms of Use

Device Description: THD PressKit is a practical and completely disposable kit composed of a probe (THD PRessProbe) and an anoscope (THD n-Ano) that, in combination with the THD Anopress allows a handy and safely execution of the THD Anal manometry. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. THD n-ano is a compact and manageable anoscope with an integrated LED light, completely disposable and packed individually. The reduced diameter and the atraumatic profile make the anoscope the ideal tool for a comfortable examination for both doctor and patient.

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":	Yes
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 [?]
K161785	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
Weight: 25 Gram
Outer Diameter: 16 Millimeter
Length: 165 Millimeter

Device Record Status

Public Device Record Key: f87dad39-c5f4-490e-9e77-35f2c02e7ef4
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
28033737711297	25	08033737711293	In Commercial Distribution	Cartoon Box
28033737711389	4	28033737711297	In Commercial Distribution	Cartoon Box
28033737711358	2	28033737711297	In Commercial Distribution	Cartoon Box
18033737711290	1	08033737711293	In Commercial Distribution	Cartoon Box