Primary Device ID | 10709078014274 |
NIH Device Record Key | e752b83d-1371-4e35-b4ff-eb187ac7b6d1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bubble Humidifier |
Version Model Number | 010-104858 |
Company DUNS | 092673953 |
Company Name | WESTMED, 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 | true |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00709078014277 [Primary] |
GS1 | 10709078014274 [Package] Contains: 00709078014277 Package: [50 Units] In Commercial Distribution |
KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-08 |
Device Publish Date | 2022-03-31 |
00709078003158 | Bubble Humidifier, Dry, High Flow |
10709078007603 | Bubble Humidifier, Dry |
10709078014281 | Concentrator Bubble Humidifier Elbow Adaptor |
10709078014274 | DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM |
10709078014090 | DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM |