FDA.report

Vital Signs™

Primary DI
20190752111346
Brand
Vital Signs™
Company
Vyaire GmbH
Model
78010
Catalog number
78010
Device description
Anesthesia Gas Sampling Line, Disposable, 2.5 m/8 ft
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Product Code Classifications

CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20190752111346PackageGS110In Commercial Distribution
10190752111349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019075211134620190752111346
1019075211134910190752111349

GMDN Terms

TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags

DUNS number
313793199
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
70190752136436Vital Signs™M1035991M10359912021-04-02
20190752139586Vital Signs™M1087562M10875622021-04-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06944413838406Patient Monitor Edan Instruments, Inc.CCL2025-09-05
04036616010856Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
04036616013871Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
10889483588628Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590058Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590065Vital Signs™AirLife Finland OyCCL2025-04-07
20889483588632Vital Signs™AirLife Finland OyCCL2025-04-02
20889483588656Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588670Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588694Vital Signs™AirLife Finland OyCCL2025-03-31
00817770025665Oxygen SensorMAXTEC, LLCCCL2024-08-14
00817770025849AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025931AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025948AnalyzerMAXTEC, LLCCCL2024-08-14
04036616009102Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
04036616010979Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
00813841022281Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00813841022298Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00817770025641Oxygen SensorMAXTEC, LLCCCL2023-06-08
00817770025658MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025689MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025788Oxygen SensorMAXTEC, LLCCCL2023-06-08
10190752190955Vital Signs™Vyaire Medical OyCCL2023-05-30
10190752190962Vital Signs™Vyaire Medical OyCCL2023-05-30
70190752191237Vital Signs™Vyaire Medical OyCCL2023-05-30
04036616010900Oxygen SensorEnviteC-Wismar GmbHCCL2022-06-17
00852470008150Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
00852470008174Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
B9671501000S3AAei Technologies, Inc.CCL2021-11-03
04250320600985O2-SensorIT Dr. Gambert GmbHCCL2021-09-24