FDA.reportPublic FDA data

Bivona

Primary DI
35021312010712
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
DRYPORT
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35021312010712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3502131201071235021312010712

GMDN Terms#

Term, Definition table
TermDefinition
Tube/mask breathing circuit connector, reusableA non-sterile device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with standardized connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It may be made of plastic and/or metal and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21
10887709194080BivonaFT26EN35NGF164N2026-05-21
10887709194097BivonaFU26EN40NSE165N2026-05-21
10887709194103BivonaFT26EN60NGA166N2026-05-21
10887709194110BivonaFU26EN30NGE167N2026-05-21
10887709194127BivonaFU26EN30NGE170N2026-05-21
10887709194134BivonaFU26EN35NGE169N2026-05-21
00887709102460ICU Medical15687-2815687-282022-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750471KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750488KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12