Kendall

Primary DI
10884527002825
Brand
Kendall
Company
Cardinal Health, Inc.
Model
50000095
Catalog number
50000095
Device description
Fetal Spiral Electrode Attachment Pad,Large
Published
2016-09-24
Public version status
Update
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
HGPELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGPElectrode, Circular (Spiral), Scalp And ApplicatorObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904745000MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEGraphic Controls Corp.1991-01-29HGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527002825PackageGS150In Commercial Distribution
20884527002822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452700282510884527002825
2088452700282220884527002822

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.75Inch
Width1.875Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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
false
Expiration date on label
true
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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340154900027Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
07340154900010Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABHGP2026-03-06
10889483588406Vital Signs™AirLife Finland OyHGP2025-03-31
20889483588403Vital Signs™AirLife Finland OyHGP2025-03-31
05055270977113RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977144RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977137RocketROCKET MEDICAL PLCHGP2023-10-24
05055270977168RocketROCKET MEDICAL PLCHGP2023-10-24
00814247021199FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
10814247021196FSECLINICAL INNOVATIONS, LLCHGP2023-09-27
00814247021205FSE CablesCLINICAL INNOVATIONS, LLCHGP2023-09-27
10192253040500KendallCardinal Health 200, LLCHGP2022-05-27
10192253021158KendallCardinal Health 200, LLCHGP2021-02-23
50192253021156KendallCardinal Health 200, LLCHGP2021-02-23
10190752142176Vital Signs™AirLife Finland OyHGP2020-12-15
50190752142174Vital Signs™Vyaire Medical OyHGP2020-12-15
10192253020977KendallCardinal Health 200, LLCHGP2020-10-30
50192253020975KendallCardinal Health, Inc.HGP2020-10-30
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HGP2020-04-16
00884838007475NAPhilips Medical Systems HsgHGP2017-07-24
00884838007468NAPhilips Medical Systems HsgHGP2017-03-14
00884838007451Fetal MeasurementsPhilips Medical Systems HsgHGP2017-01-16
20884838007431Fetal MeasurementsPhilips Medical Systems HsgHGP2016-11-08
10885403252204N/ACarefusion Finland 320 OyHGP2016-10-17
20885403252201N/ACarefusion Finland 320 OyHGP2016-10-17
10884521081123KendallCardinal Health, Inc.HGP2016-09-24
10884527004911KendallCardinal Health, Inc.HGP2016-09-24
20884527002822KendallCardinal Health, Inc.HGP2016-09-24
20884521081120KendallCardinal Health, Inc.HGP2016-09-24
20884527004918KendallCardinal Health, Inc.HGP2016-09-24