Primary Device ID | 00619498643004 |
NIH Device Record Key | 2c592fb7-be67-44c6-9f8b-6882fd7c412b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AirFit X30i |
Version Model Number | 64300 |
Company DUNS | 751149311 |
Company Name | RESMED PTY LTD |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 | true |
OTC Over-The-Counter | false |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00619498643004 [Primary] |
BZD | Ventilator, Non-Continuous (Respirator) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-17 |
Device Publish Date | 2024-12-09 |
00619498643561 | AirFit X30i LGE STPK AMER - SLM |
00619498643554 | AIRFIT X30I STD STPK AMER - SLM |
00619498643547 | AIRFIT X30I SML STPK AMER - SLM |
00619498643509 | AirFit X30i LGE STPK AMER |
00619498643011 | AIRFIT X30I STD STPK AMER |
00619498643004 | AIRFIT X30I SML STPK AMER |