Innospire Mini 1115498

GUDID 00383730004044

CUSTOM INNOSPIRE MINI ALLCARE MEDICAL.

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated

• Primary Device ID: 00383730004044
• NIH Device Record Key: 6ba59d15-b0c3-4bd5-97e5-19223bb01fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innospire Mini
• Version Model Number: 00
• Catalog Number: 1115498
• 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: true
• 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)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	00383730004044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060404

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: 2018-07-06
• Device Publish Date: 2017-11-29

On-Brand Devices [Innospire Mini]

• 00383730004044: CUSTOM INNOSPIRE MINI ALLCARE MEDICAL.
• 00383730003979: CUSTOM INNOSPIRE MINI MED4HOME, 6 pk.
• 00383730002200: Innospire Mini, Custom Southern Med.
• 00383730002194: Innospire Mini, Custom Performance Mod
• 00383730002187: Innospire Mini, Custom Medical Home.
• 00383730002170: Innospire Mini, Custom Airway Oxygen
• 00383730002163: Innospire Mini, Custom St Francis
• 00383730002156: Innospire Mini, Custom Special Care
• 00383730002149: Innospire Mini, Custom Anthem Health
• 00383730002132: Innospire Mini, Custom Kellys Med
• 00383730002125: Innospire Mini, Custom Fairview
• 00383730002118: Innospire Mini, Custom Wakefield
• 00383730002101: Innospire Mini, Custom United
• 00383730002095: Innospire Mini, Custom Royal Med
• 00383730002088: InnoSpire Mini Battery for Mini Elite, 50-pack
• 00383730002071: Innospire Mini, Battery Assembly for Mini Elite
• 00383730002064: InnoSpire Mini Battery, 50-pack
• 00383730002057: Innospire Mini Battery Assembly
• 00383730002040: Innospire Mini with Battery (UK), 6-pack
• 00383730002033: Innospire Mini with Battery (AUS), 6-pack
• 00383730002019: InnoSpire Mini w SS+ (Japan), 6-pack
• 00383730002002: InnoSpire Mini w SS+ Batt (region A), 6-pack
• 00383730001999: InnoSpire Mini w SS+ (ROW), 6-pack
• 00383730001982: InnoSpire Mini w SS+ Batt (NA), 6-pack
• 00383730001975: InnoSpire Mini w SS+ (NA), 6-pack
• 00383730001968: Innopsire Mini Compressor ASM