AccessGUDID - DEVICE: bioXtra (05425005127517)

GUDID

Device Identifier (DI) Information

Brand Name: bioXtra
Version or Model: Oral Moisturizing Gel 15ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lifestream Pharma

Primary DI Number: 05425005127517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 371031729 *Terms of Use

Device Description: A colourless, odourless gel in a plastic tube with tamper evident seal and screw-top.

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):	No
Over the Counter (OTC):	Yes
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?
47276	Oropharyngeal mucosa protection material	A substance intended to be applied to the mouth and/or pharynx to barrier/protect the mucosa from harmful influences (e.g., environmental, infectious), to treat minor pain and irritation, and/or to relieve mucosal dryness (xerostomia). It is comprised of various compounds [e.g., plant extracts, fat-soluble vitamins, hyaluronic acid (HA), glycerol/xylitol, mineral salts, viscosity enhancers, enzymes, and/or syrups]; it does not include a pharmaceutical agent. It is available in various forms (e.g., gel, toothpaste, fluid, tablet, lozenge, spray) typically for use in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFD	Saliva, Artificial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072306	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 7 and 37 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b5fd7783-edd6-4f15-be95-75df9a946524
Public Version Date: September 27, 2022
Public Version Number: 1
DI Record Publish Date: September 19, 2022