AF541 1129384

GUDID 30606959041234

AF541 EE Leak 1 UTN with Capstrap, Size B, JPN

Respironics, Inc.

CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use

• Primary Device ID: 30606959041234
• NIH Device Record Key: e01ee612-a9a3-4c94-b18d-c00b20b87157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AF541
• Version Model Number: 00
• Catalog Number: 1129384
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• 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 -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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959041233 [Primary]
GS1	30606959041234 [Package]; Contains: 00606959041233; Package: Multipack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101130

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-09

On-Brand Devices [AF541]

• 30606959046703: AF541 SE UTN,Capstrap, SIZE C
• 30606959046697: AF541 SE UTN, Capstrap, SIZE B
• 30606959046680: AF541 SE UTN, Capstrap, SIZE A
• 30606959046673: AF541 SE UTN, Capstrap, EXTRA SMALL
• 30606959046666: AF541 SE UTN, FOUR POINT HEADGEAR, SIZE C
• 30606959046659: AF541 SE UTN, FOUR POINT HEADGEAR, SIZE B
• 30606959046642: AF541 SE UTN, FOUR POINT HEADGEAR, SIZE A
• 30606959046635: AF541 SE UTN, FOUR POINT HEADGEAR, EXTRA SMALL
• 30606959046628: AF541 EE Leak 2 UTN,Capstrap, SIZE C
• 30606959046611: AF541 EE Leak 2 UTN, Capstrap, SIZE B
• 30606959046604: AF541 EE Leak 2 UTN, Capstrap, SIZE A
• 30606959046598: AF541 Non-Invasive Mask with EE Leak 2 elbow, Under the Chin cushion with Capstrap, XS
• 30606959046581: AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE C
• 30606959046574: AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE B
• 30606959046567: AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, SIZE A
• 30606959046550: AF541 EE Leak 2 UTN, FOUR POINT HEADGEAR, EXTRA SMALL
• 30606959046543: AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE C
• 30606959046536: AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE B
• 30606959046529: AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, SIZE A
• 30606959046512: AF541 EE LEAK 1 UTN, CAPSTRAP, INTL, EXTRA SMALL
• 30606959046505: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE C
• 30606959046499: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE B
• 30606959046482: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, SIZE A
• 30606959046475: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, INTL, EXTRA SMALL
• 30606959046468: AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE C
• 30606959046451: AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE B
• 30606959046444: AF541 EE LEAK 1 UTN, CAPSTRAP, US, SIZE A
• 30606959046437: AF541 EE LEAK 1 UTN, CAPSTRAP, US, EXTRA SMALL
• 30606959046420: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE C
• 30606959046413: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE B
• 30606959046406: AF541 EE LEAK 1 UTN, FOUR POINT HEADGEAR, US, SIZE A
• 30606959046390: AF541 EE LEAK 1 UTN, 4PT HEADGEAR, US, EXTRA SMALL
• 30606959041388: AF541 SE with Capstrap, Size XL, JPN
• 30606959041371: AF541 SE with Capstrap, Size L, JPN
• 30606959041364: AF541 SE with Capstrap, Size M, JPN
• 30606959041357: AF541 SE with Capstrap, Size S, JPN
• 30606959041340: AF541 SE Nasal Mask - Under the Nose Cushion with Capstrap - Replacement Part Size XS, Japan
• 30606959041333: AF541 SE UTN with Capstrap, Size C, JPN
• 30606959041326: AF541 SE UTN with Capstrap, Size B, JPN
• 30606959041319: AF541 SE UTN with Capstrap, Size A, JPN
• 30606959041302: AF541 EE Leak 1 with Capstrap, Size XL, JPN
• 30606959041296: AF541 EE Leak 1 with Capstrap, Size L, JPN
• 30606959041289: AF541 EE Leak 1 with Capstrap, Size M, JPN
• 30606959041272: AF541 EE Leak 1 with Capstrap, Size S, JPN
• 30606959041265: AF541 EE Leak 2 UTN with Capstrap, Size B, JPN
• 30606959041258: AF541 EE Leak 1 UTN with Capstrap, Size XS, JPN
• 30606959041241: AF541 EE Leak 1 UTN with Capstrap, Size C, JPN
• 30606959041234: AF541 EE Leak 1 UTN with Capstrap, Size B, JPN
• 30606959041227: AF541 EE Leak 1 UTN with Capstrap, Size A, JPN
• 30606959038845: AF541 Sizing Gauge