Bivona

GUDID 10351688738257

SMITHS MEDICAL ASD, INC.

Tracheostomy tube, non-reinforced, non-customized, reusable

• Primary Device ID: 10351688738257
• NIH Device Record Key: 23551627-70f6-4510-b988-256ca3e96ee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bivona
• Version Model Number: FT14FN50NGA085N
• 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	10351688738257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923878

FDA Product Code

• JOH: Tube tracheostomy and tube cuff

Sterilization

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

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

[10351688738257]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-09-12
• Device Publish Date: 2015-08-28

On-Brand Devices [Bivona]

• 15021312006308: 67P055
• 15021312006292: 67P050
• 15021312006285: 67P045
• 15021312006278: 67P040
• 15021312006261: 67P035
• 15021312006254: 67P030
• 15021312006247: 67P025
• 15021312006230: 67N040
• 15021312006223: 67N035
• 15021312006216: 67N030
• 15021312006209: 67N025
• 15021312006094: 670190
• 15021312006087: 670185
• 15021312006070: 670180
• 15021312006063: 670175
• 15021312006056: 670170
• 15021312006032: 670160
• 15021312006025: 670150
• 15021312006001: 65P055
• 15021312005998: 65P050
• 15021312005981: 65P045
• 15021312005974: 65P040
• 15021312005967: 65P035
• 15021312005950: 65P030
• 15021312005943: 65P025
• 15021312005936: 65N040
• 15021312000337: 65SP055
• 15021312000320: 65SP050
• 15021312000313: 65SP045
• 15021312000306: 65SP040
• 15021312000290: 65SP035
• 15021312000283: 65SP030
• 15021312000276: 65SP025
• 15021312000085: 65SN040
• 15021312000061: 65SN035
• 15021312000030: 65SN030
• 15021312000016: 65SN025
• 05021312013781: 67FHXL90
• 05021312013774: 67FHXL80
• 05021312013767: 67FHXL70
• 05021312013750: 67FHXL60
• 35021312010927: SAT757
• 35021312010910: SAT656
• 35021312010903: SAT605
• 35021312009952: BV1436
• 35021312009921: BV1255
• 35021312009914: BV1236
• 35021312009907: BV1227
• 35021312009884: BV1055
• 35021312009877: BV1036