Soteria Bed Barrier

GUDID 00850045714161

Trinity Guardion, Inc.

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• Primary Device ID: 00850045714161
• NIH Device Record Key: 1b725315-bcb2-4450-9959-7cbc2bc2026b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soteria Bed Barrier
• Version Model Number: CareAssist Therapy CASTHP-2000
• Company DUNS: 078444470
• Company Name: Trinity Guardion, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com
• Phone: 812-932-2600
• Email: info@trinityguardion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045714161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201876

FDA Product Code

• QTV: Mattress And Bed Deck Cover (Medical Purposes)

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: 2023-03-21
• Device Publish Date: 2023-03-13

On-Brand Devices [Soteria Bed Barrier]

• 00850045714192: Affinity Therapy Foot U AFTHPU-000F
• 00850045714185: Affinity Therapy Head U AFTHPU-000H
• 00850045714178: Advanta Standard ADVSTD-000S
• 00850045714161: CareAssist Therapy CASTHP-2000
• 00850045714154: CareAssist Therapy CASTHP-700S
• 00850045714147: CareAssist Standard CASSTD-000S
• 00850045714123: LD304 Foot SLD304-000F
• 00850045714116: LD304 Head SLD304-000H
• 00850045714109: Compella Therapy COMTHP-1000
• 00850045714093: InTouch IsoAir 2.0 INTAIR-4000
• 00850045714086: InTouch Isolibrium INTISO-0000
• 00850045714079: InTouch IsoTour INTITR-4000
• 00850045714062: InTouch Standard INTSTD-5000
• 00850045714055: Centrella Therapy CENTHP-0000
• 00850045714048: Progressa Therapy PRGTHP-0110
• 00850045714017: Secure II/S3 Standard S23STD-5000
• 00850045714000: VersaCare Standard VSCSTD-0000 (w/Button)
• 00850045714239: Universal 80x42x7 804207-800S
• 00850045714222: Universal 80x36x7 803607-800S
• 00850045714215: Affinity Therapy Foot V AFTHPV-000F
• 00850045714208: Affinity Therapy Head V AFTHPV-000H
• 00850045714130: MultiCare Therapy MCRTHP-9000
• 00850045714031: TotalCare Therapy TTCTHP-0110
• 00850045714253: GoBed Standard GBDSTD-5000
• 00850045714246: GoBed PositionPro GBDPOS-0000
• 00850045714024: Secure II/S3 Bed Extender S23EXT-0000
• 00850045714314: CareAssist Standard CASSTD-0000
• 00850045714307: Eleganza Therapy ELGTHP-2000
• 00850045714291: Eleganza Standard ELGSTD-0000
• 00850045714284: MultiCare Standard MCRSTD-0000
• 00850045714277: Centrella Standard CENSTD-0000
• 00850045714260: Progressa Standard PGRSTD-0000