FDA.reportPublic FDA data

Vital Signs™

Primary DI
10190752112926
Brand
Vital Signs™
Company
AirLife Finland Oy
Model
38401809
Catalog number
38401809
Device description
Leadwire Set, ECG, Grabber 12-Lead, AHA, 27 in / 70cm
Published
2018-11-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190752112926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019075211292610190752112926

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
368457563
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
true
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
10190752110663Vital Signs™2013068-0022013068-0022020-11-27
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
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
00840416607451FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
06944413830585ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830592ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830608ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830615ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830622ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830639ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830646ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830653ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830660ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830677ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830684ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830691ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830707ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830714ECG CableEdan Instruments, Inc.DSA2026-11-02
G662ME550W1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028G1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028J1MaguireMaguire Enterprises, Inc.DSA2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19