Primary Device ID | 08800124700075 |
NIH Device Record Key | a484f33e-889d-4a19-81f9-4408513c5873 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SwiftMR |
Version Model Number | A20-CL v1.3.X.X |
Company DUNS | 695823246 |
Company Name | AIRS Medical 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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800124700075 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-05-15 |
Device Publish Date | 2023-01-29 |
08800124700006 | A20-CL v1.3.X.X |
08800124700075 | A20-CL v1.3.X.X |
08800124700099 | A20-CL v3.0.X.X(v1.3.4.X(US)) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SWIFTMR 90467611 not registered Live/Pending |
Airs medical Inc. 2021-01-14 |