Primary Device ID | 00606959036550 |
NIH Device Record Key | 8800131d-3acd-4b2b-824e-bc843fa8612e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bluetooth Accessory |
Version Model Number | 00 |
Catalog Number | 1101252 |
Company DUNS | 080728314 |
Company Name | Respironics, 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 | false |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(724)744-2500 |
respironics.service@philips.com | |
Phone | +1(724)744-2500 |
respironics.service@philips.com |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00606959036550 [Primary] |
OUG | Medical device data system |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-02-28 |
00606959005143 | Bluetooth Accessory Module, International |
00606959005136 | Bluetooth Accessory Module, Canada |
00606959005129 | Bluetooth Accessory Module, Domestic |
00606959036550 | Bluetooth Accessory Module - ShellBox Assembly, Domestic |