BVF

GUDID 55099169284017

2820 30/30 BVF

VITALOGRAPH (IRELAND) LIMITED

Breathing mouthpiece, single-use

• Primary Device ID: 55099169284017
• NIH Device Record Key: adc10abd-0ed2-443a-b98c-93aae2e339c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVF
• Version Model Number: 2820
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 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 Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169284012 [Package]; Contains: 15099169284019; Package: [50 Units]; In Commercial Distribution
GS1	15099169284019 [Primary]
GS1	55099169284017 [Package]; Contains: 05099169284012; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942779

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: 2020-03-23
• Device Publish Date: 2016-11-24

On-Brand Devices [BVF]

• 55099169287681: 2820 BV FILTER TYPE K ELLIPTICAL
• 55099169287629: 2820 BV FILTER UNIVERSAL 30mm ID ELLIPTICAL
• 55099169287506: 2820 BV FILTER ELLIPTICAL
• 05099169286689: 2820 BV FILTER TYPE K MULTI-COLOR
• 05099169286627: 2820 BV FILTER UNIVERSAL 30mm ID MULTI-COLOR
• 05099169286504: 2820 BV FILTER MULTI-COLOR
• 55099169285632: 2820 Eco BVF LAB
• 05099169285576: 2820 ECO BVF WITH BITE LIP
• 05099169285545: 2820 ECO BVF WITH BITE LIP
• 55099169285021: 2820 ECO BVF WITH BITE LIP MS
• 55099169285014: 2820 Eco BVF
• 55099169284352: 2820 BVF
• 55099169284338: 2820 BVF
• 05099169284197: 2820 BV FILTER
• 55099169284178: 2820 BV FILTER
• 05099169284135: 2820 BV FILTER
• 55099169284017: 2820 30/30 BVF
• 55099169283843: BVF
• 05099169283831: 2820 BVF ELLIPTICAL M/P
• 05099169283787: 2820 BV FILTER (WHITE) - TYPE EJ
• 05099169283770: 2820 BV FILTER (BLUE) - TYPE EJ
• 05099169283763: 2820 BV FILTER TYPE J
• 05099169283756: 2820 BV FILTER
• 05099169283688: 2820 BV FILTER TYPE K
• 05099169283671: 2820 BV FILTER
• 05099169283657: 2820 BV FILTER TYPE MG
• 55099169283638: 2820 BV FILTER TYPE J - BOX OF 50
• 05099169283626: 2820 BV FILTER UNIVERSAL 30mm ID
• 55099169283508: 2820 BV FILTER