System 22 1044382

GUDID 00383730004327

SIDESTREAM TUCKER THE TURTLE MASK BX=50E

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Aerosol face mask, rebreathing

• Primary Device ID: 00383730004327
• NIH Device Record Key: 1586b85f-0b8a-4cef-a22f-e88878c8d085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System 22
• Version Model Number: 00
• Catalog Number: 1044382
• Company DUNS: 220018415
• Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730004327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940888

FDA Product Code

• BYG: MASK, OXYGEN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-28

On-Brand Devices [System 22]

• 00383730004365: MASK - SIDESTREAM PEDIATRIC
• 00383730004327: SIDESTREAM TUCKER THE TURTLE MASK BX=50E
• 00383730004280: SYSTEM 22 SYSTEM MASK PEDIATRIC-50CS
• 00383730004273: ADULT SYSTEM AEROSOL MASK -100CS
• 00383730004266: CHILD SYSTEM AEROSOL MASK (EACH)
• 00383730004259: SYSTEM 22 PEDIATRIC AEROSOL MSK SUB ASSY
• 00383730004242: SYS 22 ADULT MASK-50CS
• 00383730004235: ADULT SYSTEM AEROSOL MASK (EACH)
• 00383730004211: SYSTEM 22 ADULT AEROSOL MASK ASSEMBLY
• 00383730003948: MASK - SIDESTREAM ADULT