OPTILIFE 1036834

GUDID 00606959001435

Optilife Mask with Headgear, M, L Pillows, M, L, LN Cradle-INTL

Respironics, Inc.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00606959001435
• NIH Device Record Key: f65d66cf-f621-451b-b054-b9cc36aa2a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTILIFE
• Version Model Number: 00
• Catalog Number: 1036834
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: respironics.service@philips.co

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959001435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082558

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-20
• Device Publish Date: 2016-08-30

On-Brand Devices [OPTILIFE]

• 00606959012820: OPTILIFE MASK P, S, M, L PILLOWS, DOM
• 00606959003637: OPTILIFE MASK Subassembly No Headgear, NO CUSHIONS, DOM
• 00606959003620: OPTILIFE MASK wHEADGEAR, M, L PILLOWS M, L, LN CRADLE, DOM
• 00606959003613: OptiLife Mask wHeadgear, P, S, M Pillows, S, M, Cradle, DOM
• 00606959003606: OPTILIFE MASK wHeadgear P,S,M,L PILLOW, DOM
• 00606959001459: OPTILIFE MASK ASSEMBLY without HGR, NO CUSHIONS-INTL
• 00606959001442: OPTILIFE MASK ASSEMBLY wHeadgear, NO CUSHIONS-INTL
• 00606959001435: Optilife Mask with Headgear, M, L Pillows, M, L, LN Cradle-INTL
• 00606959001428: OPTILIFE MASK wHeadgear, P, S, M PILLOWS, S, M CRADLE-INTL
• 00606959001411: OPTILIFE MASK w Headgear, P, S, M, L PILLOWS-INTL
• 00606959038189: OptiLife Mask M, L Pillows, and M, L, LN Cradle - JPN
• 00606959038172: OptiLife Mask P, S, M Pillows, and S, M Cradle - JPN
• 00606959038165: OptiLife Mask and Headgear, P, S, M, L Pillows-JPN
• 00606959038158: OptiLife Mask Subassembly wHeadgear, No Cushion-DOM