ProChamber Assembly HS2003-050

GUDID 00383730000718

PROCHAMBER VHC - 50PK

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Medicine chamber spacer, reusable

• Primary Device ID: 00383730000718
• NIH Device Record Key: c62f5ac9-0ba5-4835-bdca-611d202c30e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProChamber Assembly
• Version Model Number: 00
• Catalog Number: HS2003-050
• 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: true
• 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: 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)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730000718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870514

FDA Product Code

• BWF: SPIROMETER, THERAPEUTIC (INCENTIVE)

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: 2018-11-12
• Device Publish Date: 2016-08-24

On-Brand Devices [ProChamber Assembly]

• 00383730000718: PROCHAMBER VHC - 50PK
• 00383730000701: PROCHAMBER WMEDIUM SILICONE MASK 50-pack
• 00383730000695: PROCHAMBER WITH SMALL SILICONE MASK 50-pack
• 00383730000688: PROCHAMBER WITH LARGE SILICONE MASK 50-pack
• 00383730000671: PROCHAMBER RETAIL - 10PK
• 00383730000664: PROCHAMBER SPAIN - 10PK
• 00383730000657: ProChamber Assembly