Primary Device ID | 00606959009387 |
NIH Device Record Key | 5a08f73f-bd34-4776-8ae3-e29e88fe206f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Amara View |
Version Model Number | 00 |
Catalog Number | 1090698 |
Company DUNS | 080728314 |
Company Name | Respironics, Inc. |
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 | false |
Lot Batch | true |
Serial Number | false |
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 |
Phone | +1 724-387-4000 |
Respironics.Service@Philips.com | |
Phone | +1 724-387-4000 |
Respironics.Service@Philips.com |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Humidity | Between 15 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 | 00606959009387 [Primary] |
BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-12 |
Device Publish Date | 2016-02-12 |
00606959009394 | Labeling - mask sizing gauge |
00606959009387 | Amara View Headgear Clip, 2 pack - replacement part |
00606959009370 | mask cushion |
00606959009356 | mask cushion |
00606959009349 | mask cushion |
00606959009332 | mask cushion |
00606959009288 | Full Face Mask |
00606959009271 | Full Face Mask |
00606959009264 | Full Face Mask |
00606959009257 | FUll Face mask |
00606959009240 | FUll Face Mask |
00606959009233 | Full Face Mask |
00606959009226 | FUll Face Mask |
00606959009219 | Full Face Mask |
00606959009202 | FUll Face mask |
00606959009196 | Full Face Mask |
00606959009189 | Full Face Mask |
00606959009172 | Full Face Mask |
00606959009165 | Full Face Mask |
00606959009158 | FUll Face Mask |
00606959009141 | Full Face Mask |
00606959009134 | Full Face Mask |
00606959024793 | Amara View Mask SE with Headgear, Large, JPN |
00606959024786 | Amara View Mask SE with Headgear, Medium, JPN |
00606959024779 | Amara View Mask SE with Headgear, Small, JPN |
00606959024762 | Amara View Mask SE with Headgear, XSmall, JPN |
00606959047068 | Amara View Mask with Headgear, Small, Iberia |
00606959047082 | Amara View Mask with Headgear, Large, Iberia |
00606959047075 | Amara View Mask with Headgear, Medium, Iberia |
00606959061385 | Amara View Mask wHGR, FitPack-RTL |