Primary Device ID | 00840106905447 |
NIH Device Record Key | 4b7e79e0-62c1-4dd7-82c0-01a128a87448 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | O2asis Humidifier |
Version Model Number | O2asis Cannula Adult |
Company DUNS | 063142533 |
Company Name | PERMA PURE LLC |
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 | true |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com | |
Phone | 866-334-2447 |
permapureqc@permapure.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810020360721 [Package] Package: Inner Pack [2 Units] In Commercial Distribution |
GS1 | 00810020360806 [Package] Package: Inner Pack [5 Units] In Commercial Distribution |
GS1 | 00840106905447 [Primary] |
BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-15 |
Device Publish Date | 2023-06-07 |
00810020360813 | O2asis Pediatric Cannula Consumable of O2asis Humidifier |
00840106905492 | O2asis Humidifier Kit |
10840106905475 | O2asis Humidifier Base Unit |
00840106905461 | O2asis Humidifier Water Well |
00810020360745 | O2asis Humidifier Water Pump |
00840106905447 | O2asis Cannula Adult Replacement consumable for the O2asis Humidifier |