FDA.report

Ambu WhiteSensor 7841P

Primary DI
05707480141654
Brand
Ambu WhiteSensor 7841P
Company
Ambu A/S
Model
7841P/5
Catalog number
7841P/5
Device description
Ambu WhiteSensor MRI Solid Gel
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DRXElectrode, electrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480141654PackageGS1150In Commercial Distribution
05707480141661PackageGS16In Commercial Distribution
05707480141647PrimaryGS10
05707480141630Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480141654057074801416545707480141654
05707480141661057074801416615707480141661
05707480141647057074801416475707480141647
05707480141630057074801416305707480141630

GMDN Terms

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

TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
5
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 DIBrandModelCatalogPublished
05707480006397Perfit Collar™0002642010002642012022-12-08
05707480006403Perfit Collar™0002642020002642022022-12-08
05707480006410Perfit Collar™0002642030002642032022-12-08
05707480006427Perfit Collar™0002642040002642042022-12-08
05707480006434Perfit Collar™0002642050002642052022-12-08
05707480006441Perfit Collar™0002642060002642062022-12-08
05707480006458Perfit Collar™0002645010002645012022-12-08
05707480006465Perfit Collar™0002645020002645022022-12-08
05707480006472Perfit Collar™0002645030002645032022-12-08
05707480006489Perfit Collar™0002645040002645042022-12-08
05707480006496Perfit Collar™0002645050002645052022-12-08
05707480018420Perfit ACE™0002810000002810002022-12-08
05707480018437Military Perfit ACE™000281000MIL000281000MIL2022-12-08
05707480006526Mini Perfit ACE™0002811060002811062022-12-08
05707480025459AuraOnce321100000U321100000U2022-12-08
05707480025473AuraOnce321200000U321200000U2022-12-08
05707480025497AuraOnce321300000U321300000U2022-12-08
05707480025503AuraOnce321400000U321400000U2022-12-08
05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860009331808EXG Radiolucent Electrode System 12-Lead ElectrodeCB Innovations, LLCDRX2026-03-09
10860009331812EXG Radiolucent Electrode System 3-Lead Posterior ElectrodeCB Innovations, LLCDRX2026-03-09
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
06946725512708APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512715APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512722APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512739APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512746APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512753APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512760APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512777APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512784APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512791APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512807APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512814APKAPK Technology Co.,Ltd.DRX2026-01-23
06946725512821APKAPK Technology Co.,Ltd.DRX2026-01-23
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