Primary Device ID | 00850045714208 |
NIH Device Record Key | 7c26c7ff-5d50-4d19-b7b4-a48932e56442 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Soteria Bed Barrier |
Version Model Number | Affinity Therapy Head V AFTHPV-000H |
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 |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com | |
Phone | 812-932-2600 |
info@trinityguardion.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850045714208 [Primary] |
QTV | Mattress And Bed Deck Cover (Medical Purposes) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-05 |
Device Publish Date | 2023-03-28 |
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 |