FDA.reportPublic FDA data

Kendall

Primary DI
20884527002822
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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884527002825PackageGS150Not in 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;

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24
10884521154100Devon31146895311468952016-09-24
10192253059984Dover7014MF7014MF2022-06-07
10884521013230Monoject888122524188812252412016-09-24
10884521013254Monoject888122524588812252452016-09-24
10884521024854Kendall923892382018-06-27
10884521004498Dover1455001455002016-09-24
10884521014091Monoject888150164088815016402016-09-24
10884521163041Magellan888185005888818500582016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
10884521518889Kangaroo888472109688847210962016-09-24

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
20884521081120KendallCardinal Health, Inc.HGP2016-09-24
20884527004918KendallCardinal Health, Inc.HGP2016-09-24
20884527002815KendallCardinal Health, Inc.HGP2016-09-24