InnoSpire Mini 1115502

GUDID 00383730002132

Innospire Mini, Custom Kellys Med

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Nebulizing system, non-heated

• Primary Device ID: 00383730002132
• NIH Device Record Key: 81338fe4-1f73-47d2-8142-11aa56b2ae3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnoSpire Mini
• Version Model Number: 00
• Catalog Number: 1115502
• 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: 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	00383730002132 [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: 2016-08-24

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• 00383730002187: Innospire Mini, Custom Medical Home.
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• 00383730002163: Innospire Mini, Custom St Francis
• 00383730002156: Innospire Mini, Custom Special Care
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• 00383730002125: Innospire Mini, Custom Fairview
• 00383730002118: Innospire Mini, Custom Wakefield
• 00383730002101: Innospire Mini, Custom United
• 00383730002095: Innospire Mini, Custom Royal Med
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• 00383730002064: InnoSpire Mini Battery, 50-pack
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• 00383730002019: InnoSpire Mini w SS+ (Japan), 6-pack
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• 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