FDA.reportPublic FDA data

AIR AUXILARY PROBE (GP 2)

Primary DI
00841034103233
Brand
AIR AUXILARY PROBE (GP 2)
Company
RPI
Model
AIP141
Catalog number
AIP141
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
00841034103233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841034103233008410341032338410341032330841034103233

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
1
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
08719689142209QMAPP Fysicon B.V.DSA2026-05-19
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19