AccessGUDID - DEVICE: inSIGHT Ultima (B019ULT1HAI0)

GUDID

Device Identifier (DI) Information

Brand Name: inSIGHT Ultima
Version or Model: ULT1-HA-I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ULT1-HA-I
Company Name: DIVERSATEK HEALTHCARE, INC.

Primary DI Number: B019ULT1HAI0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030650113 *Terms of Use

Device Description: inSIGHT Ultima® HRaM System, Int.

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:	No
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?
35053	Manometric gastrointestinal motility analysis system	An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFX	System, Gastrointestinal Motility (Electrical)

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: f117ee63-02bb-495a-bffe-b540a4807915
Public Version Date: June 14, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2016