FDA.reportPublic FDA data

SKIN TEMP PROBE - 10

Primary DI
00841034117292
Brand
SKIN TEMP PROBE - 10
Company
RPI
Model
OMP009
Catalog number
OMP009
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020219000RPI SKIN OR AIR TEMPERATURE PROBEReplacement Parts Industries, Inc.2002-04-12FMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841034117292PrimaryGS10
00841034136873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841034117292008410341172928410341172920841034117292
00841034136873008410341368738410341368730841034136873

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
818-882-8611techsupport@rpiparts.com

Regulatory Flags#

DUNS number
066232067
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841034110798ACQUISITION MODULE CABLEGEC020GEC0202016-12-09
00841034110804ACQUISITION MODULE CABLEGEC021GEC0212016-12-09
00841034112136TELEMETRY CABLE 2 LEAD SNKBB001KBB0012016-12-09
00841034112143PATIENT CABLE - 3 LEAD DNKCA001KCA0012016-12-09
00841034112150PATIENT CABLE - 3 LEAD DNKCA004KCA0042016-12-09
00841034112167PATIENT CABLE - 3 LEAD DNKCA007KCA0072016-12-09
00841034112174PATIENT CABLE - 3 LEAD DNKCA010KCA0102016-12-09
00841034112181PATIENT CABLE - 3 LEAD DNKCA013KCA0132016-12-09
00841034112198PATIENT CABLE - 3 LEAD DNKCA016KCA0162016-12-09
00841034112204PATIENT CABLE - 3 LEAD DNKCA019KCA0192016-12-09
00841034112211PATIENT CABLE - 3 LEAD DNKCA022KCA0222016-12-09
00841034112228PATIENT CABLE - 3 LEAD DNKCA025KCA0252016-12-09
00841034112235PATIENT CABLE - 3 LEAD DNKCA035KCA0352016-12-09
00841034112242PATIENT CABLE - 3 LD FX SNKCB002KCB0022016-12-09
00841034112259PATIENT CABLE - 3 LD FX SNKCB008KCB0082016-12-09
00841034112266TELEMETRY CABLE 3 LEAD SNKCB028KCB0282016-12-09
00841034112273TELEMETRY CABLE 3 LEAD SNKCB029KCB0292016-12-09
00841034112280TELEMETRY CABLE 3 LEAD SNKCB031KCB0312016-12-09
00841034112297TELEMETRY CABLE 3 LEAD PIKCB032KCB0322016-12-09
00841034112303PATIENT CABLE - 3 LD FX SNKCB036KCB0362016-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09