FDA.reportPublic FDA data

FISSO

Primary DI
07640152572906
Brand
FISSO
Company
Baitella AG
Model
3628.12
Published
2020-06-30
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640152572906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640152572906076401525729067640152572906

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00840319759325Hayden MedicalHayden Medical, Inc.FWZ2026-08-27
00840319759332Hayden MedicalHayden Medical, Inc.FWZ2026-08-25
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
00843059127331LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FWZ2026-07-20
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
00696588008394De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-06-23
00848530108809Ventilator accessorySunset Healthcare Solutions, Inc.CAI2026-04-27
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
B382SD40090530Surgical DirectSurgical Direct, Inc.FWZ2025-08-05
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18
10889483591925Vital Signs™AIRLIFECAI2025-02-18
10889483591987Vital Signs™AIRLIFECAI2025-02-18
10889483592113Vital Signs™AIRLIFECAI2025-02-18