PFM

GUDID 55099169439509

my PEF PEAK FLOW METER

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, manual Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable Expiratory peak flow meter, analogue, reusable

• Primary Device ID: 55099169439509
• NIH Device Record Key: 9119657d-703d-41ee-887b-1b6aadd96b20
• 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
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169439504 [Primary]
GS1	35099169439505 [Package]; Contains: 05099169439504; Package: [25 Units]; In Commercial Distribution
GS1	55099169439509 [Package]; Contains: 35099169439505; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781922

FDA Product Code

• BXW: CALIBRATOR, VOLUME, GAS

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: 2016-12-08

On-Brand Devices [PFM]

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• 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
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• 35099169434005: 4300 PEAK FLOW METER GERMAN
• 55099169430001: 4300 PEAK FLOW METER C/W CARTON GERMAN
• 55099169439110: 4300 PEAK FLOW METER