FDA.reportPublic FDA data

FISSO

Primary DI
07640152573187
Brand
FISSO
Company
Baitella AG
Model
3590.30-4127
Published
2021-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640152573187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640152573187076401525731877640152573187

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit tube holderA device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41443058000info@baitella.com

Regulatory Flags#

DUNS number
484942081
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640152574245FISSO5.870-VE5.870-VE2026-04-01
07640152574252FISSO5.871-VE5.871-VE2026-04-01
07640152574269FISSO5.872-VE5.872-VE2026-04-01
07640152574276FISSO5.873-VE5.873-VE2026-04-01
07640152574283FISSO6740.006740.002026-04-01
07640152572197FISSO 3855.602016-09-16
07640152573330FISSO3840.642023-06-08
07640152573989FISSO6740.00-17476740.00-17472025-10-13
07640152573620FISSO5.750-23662024-07-15
07640152572982FISSO5.750-23662020-04-09
07640152573323FISSO3628.13-17472024-02-02
07640152573002FISSO3640.132023-10-30
07640152573668FISSO 6646.03-50342023-05-15
07640152572708FISSO5.752-VE2023-04-27
07640152573354FISSO3690.31-17862021-06-17
07640152573651FISSO 3855.412023-03-27
07640152573477FISSO 4646.082023-02-20
07640152573484FISSO 4670.042023-02-20
07640152573491FISSO 6646.032023-02-20
07640152573507FISSO 6656.042023-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27
10889483572160AirLife™AIRLIFEBZO2025-03-27
10889483588246AirLife™AIRLIFEBZO2025-03-27
10889483570227AirLife™AIRLIFEBZO2025-03-18
10889483570289AirLife™AIRLIFEBZO2025-03-18
10889483570326AirLife™AIRLIFEBZO2025-03-18
10889483570517AirLife™AIRLIFEBZO2025-03-06
10889483571705AirLife™AIRLIFEBZO2025-03-05
10889483570548AirLife™AIRLIFEBZO2025-02-26
10889483570708AirLife™AIRLIFEBZO2025-02-26
10889483570173AirLife™AIRLIFEBZO2025-02-25
10889483570197AirLife™AIRLIFEBZO2025-02-25
10889483570203AirLife™AIRLIFEBZO2025-02-25
10889483570210AirLife™AIRLIFEBZO2025-02-25