INNSOPIRE GO Europe1ROW 1126593

GUDID 00383730000534

INNSOPIRE GO Europe1ROW

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Ultrasonic nebulizing system Ultrasonic nebulizing system

• Primary Device ID: 00383730000534
• NIH Device Record Key: e176dc0c-d57a-4eb5-a612-53e2f66cc257
• Commercial Distribution Discontinuation: 2050-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNSOPIRE GO Europe1ROW
• Version Model Number: 00
• Catalog Number: 1126593
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730000534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170853

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-11-09

Devices Manufactured by RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

• 00383730004648 - OVAL MOUTHPIECE: 2020-06-19 OVAL MOUTHPIECE
• 00383730004624 - PLASTIC PEDIATRIC MOUTHPIECES (715)100PK: 2020-06-17 PLASTIC PEDIATRIC MOUTHPIECES (715)100PK
• 00383730004631 - PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE: 2020-06-17 PLASTIC PEDIATRIC DISPOSABLE MOUTHPIECE
• 00383730004617 - OVAL DISPOSABLE PLASTIC MOUTHPIECE: 2020-06-15 OVAL DISPOSABLE PLASTIC MOUTHPIECE
• 00383730004495 - TBM MP Gold Chamber Assy Tested: 2020-04-01 Tidal Breathing Mode Mouthpiece Gold Chamber Assembly Tested
• 00383730004501 - I-neb Clinical Study Disc: 2020-04-01 I-neb Clinical Study Disc
• 00383730004518 - I-neb Generic ClinicalStudy Disc Power10: 2020-04-01 I-neb Generic Clinical Study Disc Power10
• 00383730004587 - I-neb In Vitro Test Disc Power 10: 2020-04-01 I-neb In Vitro Test Disc Power 10