FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752110663
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
2013068-002
Catalog number
2013068-002
Device description
Infant/Neonatal Airway Adapter for CapnoFlex Module
Published
2020-11-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752110661PackageGS110Not in Commercial Distribution
10885403252716PreviousGS10
10190752110663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075211066150190752110661
1088540325271610885403252716
1019075211066310190752110663

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected 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] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1-833-327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
368457563
Device count
1
DM exempt
false
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752110588Vital Signs™2013066-0042013066-0042020-11-27
10190752110595Vital Signs™2013066-0052013066-0052020-11-27
10190752110601Vital Signs™2013066-0072013066-0072020-11-27
10190752110632Vital Signs™2013067-0032013067-0032020-11-27
10190752110649Vital Signs™2013067-0042013067-0042020-11-27
10190752110656Vital Signs™2013068-0012013068-0012020-11-27
10190752110670Vital Signs™2013068-0032013068-0032020-11-27
10190752110687Vital Signs™2013068-0042013068-0042020-11-27
10190752110755Vital Signs™415036-001415036-0012020-11-27
10190752110762Vital Signs™415036-002415036-0022020-11-27
10190752140882Vital Signs™900604-003900604-0032021-01-28
10190752140899Vital Signs™900604-004900604-0042021-01-28
10190752140905Vital Signs™900604-005900604-0052021-01-28
10889483581223Vital Signs™38401809384018092025-04-02
10190752112926Vital Signs™38401809384018092018-11-23
10190752179981Vital Signs™38401809384018092020-12-17
10190752110724Vital Signs™412341-001412341-0012020-11-27
10190752139749AirLife™85702302019-09-01
10889483590591AirLife™857023085702302025-04-02
10190752140912Vital Signs™M1031274M10312742021-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109721OXYGEN CONNECTOR/ADAPTERSunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109820Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109837Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
06923980103629N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980107672N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980111969N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
04719874959197Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to MaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to FemaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
00848530107925Tracheostomy and SuctionSunset Healthcare Solutions, Inc.BZA2025-12-09
00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106317Ventilator CircuitSunset Healthcare Solutions, Inc.BZA2025-07-15
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03
00848530097363Ventilator AccessorySunset Healthcare Solutions, Inc.BZA2025-05-21