bioXtra

GUDID 05425005127517

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

Lifestream Pharma

Oropharyngeal mucosa protection material

• Primary Device ID: 05425005127517
• NIH Device Record Key: b5fd7783-edd6-4f15-be95-75df9a946524
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioXtra
• Version Model Number: Oral Moisturizing Gel 15ml
• Company DUNS: 371031729
• Company Name: Lifestream Pharma
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx
• Phone: 636-527-2288
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425005127517 [Primary]
GS1	05425005127524 [Package]; Package: carton box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072306

FDA Product Code

• LFD: Saliva, Artificial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-27
• Device Publish Date: 2022-09-19