PERSONAL BEST 1024941

GUDID 00383730000398

PERSONAL BEST ISO ASSEMBLY

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Peak flow meter, manual

• Primary Device ID: 00383730000398
• NIH Device Record Key: 2a6af86e-efb1-4be9-81b4-81d0c0b8b120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERSONAL BEST
• Version Model Number: 00
• Catalog Number: 1024941
• 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	00383730000398 [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

On-Brand Devices [PERSONAL BEST]

• 00383730000480: PERSONAL BEST LR PFM (756EU)-CEG
• 00383730000473: PERSONAL BEST LR PFM (756)-12PK
• 00383730000466: PERSONAL BEST LR PFM-RUSSIA-SINGLE UNIT
• 00383730000459: PERSONAL BEST LR PFM ASSY
• 00383730000442: PERSONAL BEST FR PFM-RUSSIA-SINGLE UNIT
• 00383730000435: PERSONAL BEST FR PFM (755) - 12PK
• 00383730000428: PERSONAL BEST FR PFM ASSY
• 00383730000411: PERSONAL BEST FR PFM - CEGLA (ISO 23747)
• 00383730000404: PERSONAL BEST FR PFM ISO-23747 SINGLE
• 00383730000398: PERSONAL BEST ISO ASSEMBLY