Primary Device ID | M995922006103 |
NIH Device Record Key | 3e8d31e2-9a83-493d-a35d-140c6b66891c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Calibration Hose Set for PTS BFR, plastic Female |
Version Model Number | 9-2200-610 |
Company DUNS | 251078945 |
Company Name | Delfi Medical Innovations Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com | |
Phone | 16047420600 |
info@delfimedical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M995922006103 [Primary] |
KCY | Tourniquet, Pneumatic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-02 |
Device Publish Date | 2023-05-25 |
M995979500181 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
M995979500241 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
M995979500341 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
M995979500441 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
M995601000212001 - PTS Hose Set | 2023-06-02 Hose set for use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00 |
M995601000234001 - Calibration Hose Set | 2023-06-02 Calibration Hose set for the use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00 |
M995922000243 - PTS Hose Set - Single (Female Connector) | 2023-06-02 PTS Hose Set (Female metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR) |
M995922000253 - PTS Hose Set - Single (Male Connector) | 2023-06-02 PTS Hose Set (Male metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR) |