Spirometry PC Software Update 36-SPCU100-STK

GUDID 34250892980264

Spirometry PC Software Update

CAREFUSION U.K. 232 LIMITED

Pulmonary function analysis system, adult

• Primary Device ID: 34250892980264
• NIH Device Record Key: 35d96081-7812-49aa-ae19-c47e511269ff
• Commercial Distribution Discontinuation: 2019-05-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Spirometry PC Software Update
• Version Model Number: 2.5
• Catalog Number: 36-SPCU100-STK
• Company DUNS: 291555621
• Company Name: CAREFUSION U.K. 232 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: +499314972127
• Email: support.rt.eu@carefusion.com
• Phone: +499314972127
• Email: support.rt.eu@carefusion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	34250892980264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141936

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-28
• Device Publish Date: 2017-10-27

Devices Manufactured by CAREFUSION U.K. 232 LIMITED

• 34250892980196 - Micro Medical: 2020-03-23 Adult Mouthpieces one way
• 34250892980202 - Micro Medical: 2020-03-23 Adult Mouthpieces one way
• 34250892980219 - Micro Medical: 2020-03-23 Adult Mouthpieces
• 34250892980226 - Micro Medical: 2020-03-23 Paediatric Mouthpieces
• 14250892980185 - Micro Medical: 2020-02-24 Rubber Flanged Mouthpiece
• 54250892980145 - Micro Medical: 2020-02-11 SmokeCheck
• 34250892980233 - Spirometry PC Software: 2019-05-28 Spirometry PC Software
• 34250892980257 - Spirometry PC Software Licence: 2019-05-28 Spirometry PC Software Licence