AccessGUDID - DEVICE: Digitrapper (07290101362906)

GUDID

Device Identifier (DI) Information

Brand Name: Digitrapper
Version or Model: 800004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Given Imaging, Inc.

Primary DI Number: 07290101362906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 090073722 *Terms of Use

Device Description: recorder, pH-Z

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?
36965	Gastric pH ambulatory recorder	An electrically-powered device intended for 24-hour recording of the gastric acidity of the stomach through the use of a dedicated sensor. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The results will be later analysed using an appropriate device that can read and display the recording.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFT	Electrode, pH, stomach

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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry;Fragile

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf18a805-6919-4b97-93d3-dbd048081acf
Public Version Date: November 15, 2024
Public Version Number: 5
DI Record Publish Date: August 29, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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