PFM

GUDID 55099169439813

4300 PEAK FLOW METER

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, manual

• Primary Device ID: 55099169439813
• NIH Device Record Key: d676a0f4-fbf8-4d13-b5d4-5e80ddafc23c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFM
• Version Model Number: 4300
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• 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: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169439818 [Primary]
GS1	35099169439819 [Package]; Contains: 05099169439818; Package: [25 Units]; In Commercial Distribution
GS1	55099169439813 [Package]; Contains: 35099169439819; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781922

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: 2016-12-09

On-Brand Devices [PFM]

• 35099169439970: 4300 PEAK FLOW METER myPEF
• 35099169439932: 4300 PEAK FLOW METER myPEF
• 35099169439918: 4300 PEAK FLOW METER
• 35099169439840: 4300 PEAK FLOW METER myPEF
• 35099169439833: 4300 PEAK FLOW METER myPEF SWITZERLAND
• 55099169439813: 4300 PEAK FLOW METER
• 55099169439509: my PEF PEAK FLOW METER
• 55099169439035: 4300 PEAK FLOW METER myPEF UNIVERSAL DE (NON WEB)
• 55099169439004: 4300 PEAK FLOW METER myPEF (NON WEB)
• 35099169438218: 4300 PEAK FLOW METER ADULT
• 35099169437037: 4300 PEAK FLOW METER CHILD
• 35099169436023: 4300 PEAK FLOW METER
• 35099169434005: 4300 PEAK FLOW METER GERMAN
• 55099169430001: 4300 PEAK FLOW METER C/W CARTON GERMAN
• 55099169439110: 4300 PEAK FLOW METER