AccessGUDID - DEVICE: 13C-Spirulina GEBT (M763K0211)

GUDID

Device Identifier (DI) Information

Brand Name: 13C-Spirulina GEBT
Version or Model: K021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED BREATH DIAGNOSTICS, LLC

Primary DI Number: M763K0211
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055362540 *Terms of Use

Device Description: 13C-Spirulina Gastric Emptying Breath Test (GEBT)

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:	Yes
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?
61476	Carbon isotope breath test kit IVD	A collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGE	Gastric Emptying Breath Test

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P110015	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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d886a74-c9e5-4d15-8355-f072c7795ce6
Public Version Date: June 06, 2024
Public Version Number: 5
DI Record Publish Date: October 13, 2015

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

Customer Contact

[?]

Phone: +1 615 376 5464
Email: cwilliams@cairndx.com

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

FDA TOOLS & RESOURCES