SideStream HS870

GUDID 00383730001371

SideStream Plus Nebulizer, Case of 10.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 00383730001371
• NIH Device Record Key: 931c7594-cf9f-47bb-acd8-5bd3e4984a58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SideStream
• Version Model Number: 00
• Catalog Number: HS870
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730001371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062689

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

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 [SideStream]

• 00383730004402: Sidestream Plus Patient Pack Retail
• 00383730001609: SideStream Custom Nebulizer Kit, Case of 25
• 00383730001593: Sidestream Pulmochoice Nebulizer w Pediatric Mask, 50-pack
• 00383730001586: Sidestream Pulmochoice Nebulizer w Adult Mask, 50-pack
• 00383730001579: SideStream, Primary Care Packs x 40, Case of 40
• 00383730001562: SideStream with Child Mask and Tubing, 50 pack.
• 00383730001555: Sidestream Pulmochoice Nebulizer Tubing, 50-pack
• 00383730001548: SideStream Disposable Nebulizer, Case of 50
• 00383730001531: SideeStream Disposable, Tubing, Angle MP, 50-pack
• 00383730001524: SideStream Disposable Nebulizer and Adult Mask and Tubing, 50-pack
• 00383730001517: Sidestream, Disposable, Case of 200.
• 00383730001500: SideStream Dispoable, Case of 50
• 00383730001494: SideStream DIsposable with Angled Mouthpiece, Case of 100
• 00383730001487: SideStream Disposable and Pediatric Mask, case of 50 ea
• 00383730001470: SideStream Disposable Adult Mask 50-pack
• 00383730001463: SideStream Disposable Tubing, 50-case
• 00383730001456: SideStream Disposable and Tubing and Child Mask, 50 - case
• 00383730001449: SideStream Tubing and Adult Mask, 50-case
• 00383730001432: SideStream Disposable, 250-Case
• 00383730001425: Sidestream Assembly 2009
• 00383730001418: Sidestream Filter Kit, 60 pack.
• 00383730001401: SideStream Plus Filter Kit
• 00383730001395: Sidestream Plus 50 PK.
• 00383730001388: SideStream Plus Nebulizer (each).
• 00383730001371: SideStream Plus Nebulizer, Case of 10.
• 00383730001364: SideStream Plus (EU) with Aerosol Hose, 10 pack.
• 00383730001357: SideStream Plus (EU) with Mouthpiece, 40 pack.
• 00383730001340: SideStream Plus (EU) with Filter, 10 pack.
• 00383730001333: SideStream Plus Nebulizer - Japanese, 10 pack.
• 00383730001326: SideStream Plus Assembly
• 00383730001319: Sidestream Patient Pack, Retail, 10 pack.
• 00383730001302: SideStream Patient Pack (Norway), 50-pack
• 00383730001296: SideStream Paitent Pack, 50 pack.
• 00383730001289: SideStream Reusable Nebulizer, 50 pack.
• 00383730001272: SideStream Reusable Nebulizer, (each).
• 00383730001265: SideStream Reusable Nebulizer, Case of 10.
• 00383730001258: SideStream Reusable and Tuck Mask PT PK, 50 pack.
• 00383730001241: Sidestream Reusable Nebulizers [2], 12-pack
• 00383730001234: SideStream Reusable Retail Kit, 10-pack
• 00383730001227: SideStream Durable Bebulizer, Case of 10.
• 00383730001210: SideStream Durable Kit with Mouthpiece, 50 pack.
• 00383730001111: Sidestream Durable, Child Kit, 50 pack.
• 00383730001104: Sidestream Durable, Adult Kit, 50 pack.
• 00383730001098: SideStream Durable Nebulizer, 200 pack.
• 00383730001081: SideStream Reusable with Tucker Mask, Retail, 10-pack
• 00383730001074: Sidestream Reusable Kit, box of 250
• 00383730001067: SideStream Durable, Case of 50.
• 00383730001050: SideStream Reusable Kit, RISZ