FDA.reportPublic FDA data

Vital Signs™

Primary DI
50190752110685
Brand
Vital Signs™
Company
Vyaire Medical Oy
Model
2013068-004
Catalog number
2013068-004
Device description
Infant/Neonatal Airway Adapter with Dehumidification Tubing for CapnoFlex Module
Published
2020-11-27
Public version status
New
Distribution status
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
50190752110685PackageGS110In Commercial Distribution
10885403252730PreviousGS10
10190752110687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075211068550190752110685
1088540325273010885403252730
1019075211068710190752110687

GMDN Terms#

Term, Definition table
TermDefinition
Gas dehumidification tubing set, single-useA collection of devices intended to be used for the purpose of dehumidifying exhaled gas prior to its analysis in a gas analyser. It is composed of a length of hollow tubing made from one of several malleable or semi-rigid materials (e.g., silicone, plastic, rubber or nylon) and an integrated filter which absorbs (subtracts) the humidity from the gases before they enter the analysing chamber of the parent device. It has a limited lifetime and may be exchanged by the user, in which case it will typically be located on the outside of the parent device. This is a single-use device.

Sterilization Methods#

Method table
Method

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
20190752141251Multi-Link™2086367-0032086367-0032021-01-14
20190752141268Multi-Link™2086367-0042086367-0042021-01-14
20190752101729Multi-Link™2086367-0062086367-0062021-01-14
70190752191237Vital Signs™M1031274M10312742023-05-30
50190752117912Vital Signs™7331882019-09-01
50190752117929Vital Signs™7331992019-09-01
50190752117172Vital Signs™73318-HEL2019-09-01
50190752117189Vital Signs™73319-HEL2019-09-01
50190752117493Vital Signs™733062019-09-01
20190752188188Vital Signs™2464AAO-202464AAO-202022-03-18
70190752139840AirLife™5570195002019-09-01
70190752139857AirLife™5570701002019-09-01
70190752139864AirLife™5570705002019-09-01
70190752139871AirLife™5570707002019-09-01
70190752139888AirLife™5570715002019-09-01
70190752139895AirLife™5570716002019-09-01
70190752139901AirLife™5570855002019-09-01
70190752139918AirLife™80042312019-09-01
70190752139925AirLife™85702032019-09-01
70190752139932AirLife™M10041322019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10889483225271AirLife™SUNMED, LLCBZA2025-12-18
10889483225660AirLife™SUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
10884521084995DARCovidien LPBZA2025-04-12
10884521842533DARCovidien LPBZA2025-04-12
10884522019743DARCovidien LPBZA2025-04-12
10884522019750DARCovidien LPBZA2025-04-12
10884522019774DARCovidien LPBZA2025-04-12
10884522019781DARCovidien LPBZA2025-04-12
10884522019804DARCovidien LPBZA2025-04-12
10884522019811DARCovidien LPBZA2025-04-12
10884522019828DARCovidien LPBZA2025-04-12
10884522019835DARCovidien LPBZA2025-04-12
10884522019842DARCovidien LPBZA2025-04-12
10884522019859DARCovidien LPBZA2025-04-12
10884522019866DARCovidien LPBZA2025-04-12
10884522019873DARCovidien LPBZA2025-04-12
10884522019880DARCovidien LPBZA2025-04-12
10884522019897DARCovidien LPBZA2025-04-12