FDA.reportPublic FDA data

Ambu WhiteSensor 7841PECG Electrodes

Primary DI
05707480129836
Brand
Ambu WhiteSensor 7841PECG Electrodes
Company
Ambu A/S
Model
7841P
Catalog number
7841P
Device description
Ambu White Sensor 7841P Electrod with Bio-Tack sticky gel and cleartape backing. With center snap and PVC free. Radiolucent and MR Conditional. Packag
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480129829PackageGS110In Commercial Distribution
05707480129836PackageGS112In Commercial Distribution
05707480129812PrimaryGS10
05707480129355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480129829057074801298295707480129829
05707480129836057074801298365707480129836
05707480129812057074801298125707480129812
05707480129355057074801293555707480129355

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
60
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05707480135363SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5206111015206111012017-10-13
05707480135585SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5236310115236310112018-07-09
05707480135615SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator5306390115306390112017-10-13
05707480136018SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator5442160475442160472018-05-28
05707480145294SPUR® II Adult Resuscitator5246140005246140002020-06-24
05707480145317SPUR® II Pediatric Resuscitator5316160005316160002020-06-24
05707480145348SPUR® II Adult Resuscitator5206110745206110742020-06-24
05707480145393SPUR® II Adult Resuscitator520211000BE520211000BE2021-04-13
05707480145416SPUR® II Adult Resuscitator520211000E520211000E2021-04-13
05707480145430SPUR® II Adult Resuscitator520211001E520211001E2021-04-13
05707480145454SPUR® II Adult Resuscitator520211010E520211010E2021-04-13
05707480145478SPUR® II Adult Resuscitator520214000E520214000E2021-04-13
05707480145492SPUR® II Adult Resuscitator520611000E520611000E2021-04-13
05707480145515SPUR® II Adult Resuscitator521611000E521611000E2021-04-13
05707480145539SPUR® II Adult Resuscitator523211000E523211000E2021-04-13
05707480145553SPUR® II Adult Resuscitator523211001E523211001E2021-04-13
05707480145577SPUR® II Adult Resuscitator523611030E523611030E2021-04-13
05707480145591SPUR® II Adult Resuscitator523611031E523611031E2021-04-13
05707480027354SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110005232110002016-12-19
05707480027361SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator5232110015232110012016-12-19

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Primary DI, Brand, Company table
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10860009331898EXG Radiolucent Electrode System 4-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
00860009331853EXG Radiolucent Electrode 5-Lead Cardiac Rhythm ElectrodeCB Innovations, LLCDRX2026-03-05
30009336010593Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
30009336010609Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPDRX2026-02-26
08033315120394BIONENBIONEN SAS DI BARBARA NENCIONI & C.DRX2026-02-16
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00853512006998NIKOTRACENIKOMED USADRX2026-01-23
06946725512685APKAPK Technology Co.,Ltd.DRX2026-01-20
06946725512692APKAPK Technology Co.,Ltd.DRX2026-01-20
29005531002764SkintactLeonhard Lang GmbHDRX2026-01-15
29005531003044SkintactLeonhard Lang GmbHDRX2026-01-14
04719872981640QT ECGQt Medical, Inc.DRX2025-12-30
06946725512364APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512371APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512388APKAPK Technology Co.,Ltd.DRX2025-12-25
06946725512395APKAPK Technology Co.,Ltd.DRX2025-12-25