Primary Device ID | 20627825011116 |
NIH Device Record Key | dd3de960-af50-4f50-8399-c5cfea14de08 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TDOC Air-Charged 7Fr Single Lumen, Single Sensor Abdominal Catheter |
Version Model Number | CATT3A17 |
Company DUNS | 203383526 |
Company Name | Laborie Medical Technologies Canada ULC |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00627825011112 [Primary] |
GS1 | 10627825011119 [Package] Contains: 00627825011112 Package: [10 Units] In Commercial Distribution |
GS1 | 20627825011116 [Package] Contains: 10627825011119 Package: [10 Units] In Commercial Distribution |
FEN | Device, Cystometric, Hydraulic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-01-28 |
Device Publish Date | 2018-12-27 |
30627825007024 - Extension Set 2 | 2022-07-04 |
20627825007294 - Extension Line, 60 cm | 2022-07-04 |
20627825007317 - Extension Line, 1500mm | 2022-07-04 |
20627825007324 - Extension Line, 15cm | 2022-07-04 |
20627825007348 - Extension Line, 150cm Blue | 2022-07-04 |
30627825007352 - Extension Line, 150cm Yellow | 2022-07-04 |
20627825007034 - Extension Set 3 | 2022-07-04 |
30627825007307 - Extension Line, 90 cm | 2022-07-04 |