PERSONAL BEST FR PFM - AUSTRALIA 1050365

GUDID 00383730000619

PERSONAL BEST FR PFM - AUSTRALIA

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Peak flow meter, manual Peak flow meter, manual

• Primary Device ID: 00383730000619
• NIH Device Record Key: 8709d04c-01c6-4115-b0c7-b223fc5a124a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONAL BEST FR PFM - AUSTRALIA
• Version Model Number: 00
• Catalog Number: 1050365
• 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: false
• OTC Over-The-Counter: true

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	00383730000619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912866

FDA Product Code

• BZH: METER, PEAK FLOW, SPIROMETRY

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

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