Bivona

GUDID 15021312000665

SMITHS MEDICAL ASD, INC.

Basic tracheostomy tube, reusable

• Primary Device ID: 15021312000665
• NIH Device Record Key: 118c0d56-7c7d-4176-bfc8-4e8994e86307
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bivona
• Version Model Number: 67SP025
• Company DUNS: 118112924
• Company Name: SMITHS MEDICAL ASD, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15021312000665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083641

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [Bivona]

• 05021312013781: 67FHXL90
• 05021312013774: 67FHXL80
• 05021312013767: 67FHXL70
• 05021312013750: 67FHXL60
• 15019517185577: FU19CN45NGF924N
• 15019517185560: HU19CS70NSC925N
• 15019517185553: FU19CN30NGE926N
• 15019517185539: FU19CN45NSC927N
• 15019517185522: ST19CN55NGF928N
• 15019517185508: FT19CN40NGE929N
• 15019517185492: FT19CN35NGE930N
• 15019517185485: SP19CN40NSC931N
• 15019517185461: HU19CS70NSC932N
• 15019517185430: FP19CN40NGE100N
• 15019517185423: FT16CN45NSA015N
• 15019517185416: FT19CN40NGA085N
• 15019517185409: SU18AN45NGG018N
• 15019517185393: FT19CN40NSA099N
• 15019517185386: FT19CN50NSF098N
• 15019517185379: FP19CN50NGA101N
• 15019517185362: FT19CN40NGE097N
• 15019517185331: FT19CN80NSC096N
• 15019517185294: FT19CN40NSG095N
• 15019517185270: SU19CN40NGF094N
• 15019517185751: FT19CN30NGE917N
• 15019517185744: FT19CN35NGE918N
• 15019517185720: FT19CN35NGE919N
• 15019517185713: FT19CN35NGE920N
• 15019517185706: FA19CN85NSC921N
• 15019517185669: SU14FN60NSC093N
• 15019517185652: HA19CS80ZSC112N
• 15019517185638: FU19CN35NSA109N
• 15019517185621: FT19CN30NGC111N
• 15019517185614: FT19CN35NGC110N
• 15019517185607: FT19CN40NSA108N
• 15019517185591: FT19CN40NGA103N
• 15019517185584: FT19CN40NGA102N
• 15019517185546: FT19CN40NGE104N
• 15019517185515: FT19CN40NGE107N
• 15019517185478: FT19CN40NGF106N
• 15019517185454: XT19CS45NSF105N
• 15019517185447: FU19CN35NGE093N
• 15019517185935: XT19CS80NSC905N
• 15019517185928: SU19CN45NSC906N
• 15019517185911: FT19CN70NSC908N
• 15019517185904: ST19CN55NSB909N
• 15019517185898: FT19CN30NGC910N
• 15019517185881: FT19CN35NGC911N
• 15019517185874: FT19CN50NSC912N
• 15019517185867: FU19CN55NSC913N