FDA.reportPublic FDA data

bioXtra

Primary DI
05425005127517
Brand
bioXtra
Company
Lifestream Pharma
Model
Oral Moisturizing Gel 15ml
Device description
A colourless, odourless gel in a plastic tube with tamper evident seal and screw-top.
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072306000BIOXTRA MOISTURIZING GELBio-X Healthcare S.A.2007-11-15LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425005127524PackageGS1100In Commercial Distribution
05425005127517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425005127524054250051275245425005127524
05425005127517054250051275175425005127517

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal mucosa protection materialA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature7 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
636-527-2288xxx@xx.xx

Regulatory Flags#

DUNS number
371031729
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350930098029Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00350930098081Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00858290006987Allday Oral Moisturizing Rinse, 10oz BottleELEVATE ORAL CARE, LLCLFD2026-05-01
00810051089004GuruNandaGurunanda, LLCLFD2026-01-28
00810051089479GuruNandaGurunanda, LLCLFD2026-01-28
00647692000132CloSYS Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.LFD2025-12-16
00899655002220SaliveaLACLEDE, INC.LFD2025-06-16
00697366003556SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00697366003570SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00850058655086Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655055Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655109Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
05060146293129Caphosol® Artifical SalivaEUSA PHARMA (UK) LIMITEDLFD2024-06-26
08426181972769Xerostom® Saliva Substitute GelBIO COSMETICS SLLFD2024-04-01
05060146291576CaphosolEUSA PHARMA (UK) LIMITEDLFD2024-03-27
00304369600421Moi-stir 4 oz w/ sprayerCentury Pharmaceuticals IncLFD2024-02-14
00370275629047SalivaMAXForward Science Technologies LLCLFD2024-02-14
D132DMS0020CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
D132DMS0030MeijerOralabs, LLCLFD2024-01-29
00050428446102CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
00708820384446MeijerOralabs, LLCLFD2024-01-29
00858290006895Povi-OneELEVATE ORAL CARE, LLCLFD2023-09-27
00899655002213SaliveaLACLEDE, INC.LFD2023-09-22
00899655002251Salivea LACLEDE, INC.LFD2023-09-12
00899655002275SaliveaLACLEDE, INC.LFD2023-09-12
D132DMS0010CVS Dry Mouth SprayOralabs, LLCLFD2023-08-14
00858290006871Allday Spray/Gel Sample BagELEVATE ORAL CARE, LLCLFD2023-05-18
00048582001558BioteneHaleon US Holdings LLCLFD2023-04-14
00048582003309BioteneHaleon US Holdings LLCLFD2023-04-14
00048582004566BioteneHaleon US Holdings LLCLFD2023-04-14