FDA.reportPublic FDA data

ECG Cable Assembly and Module

Primary DI
00841517108786
Brand
ECG Cable Assembly and Module
Company
FUJIFILM SONOSITE, INC.
Model
P29076-10
Catalog number
P29076
Device description
Diagnostic Ultrasound System Accessory
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213763000
K233597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213763000Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.2021-12-27IYN
K233597000Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.2023-12-06IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841517108786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841517108786008415171087868415171087860841517108786

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-35 Degrees Celsius65 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014438860
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841517112684C5-1P23119-30AP231192026-08-07
00841517112011iLOOKP33873-10P338732026-07-16
00841517112028iLOOKP33874-10P338742026-07-16
00841517112035iLOOKP35003-10P350032026-07-16
00841517112462iLOOKP35004-04P350042026-07-16
00841517139018iLOOKP35000-10P350002026-07-16
00841517112653rP19x/5-1 MHz ArmoredP21556-22A2026-06-24
00841517112660L12-3P22916-23AP229162026-06-24
00841517112677L15-4P23120-23AP231202026-06-24
00841517112646L15-4P23120-232026-06-23
00841517112639L12-3P22916-23P229162026-06-22
00841517112622Sonosite STP31200-60P312002026-05-01
00841517112585L19-5P23972-25AP239722026-04-17
00841517112493C5-1P23119-30P231192026-03-30
00841517112561Sonosite PXP25000-60P250002026-03-12
00841517112530H-Universal StandP23119-25AP231192026-01-09
00841517112486rP19x/5-1 MHzP22557-11AP225572025-12-23
00841517112455L19-5P23972-25P239722025-12-18
00841517112479C5-1P23119-25P231192025-12-17
00841517111892Sonosite MTP33004-04P330042025-11-24

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00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
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