FDA.report

BIOTABSECG Electrodes

Primary DI
05707480129102
Brand
BIOTABSECG Electrodes
Company
Ambu A/S
Model
0415M/SCHI
Catalog number
0415M/SCHI
Device description
TAB SCHILLER 22.8X34mm
Published
2016-12-06
Public version status
Update
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
05707480129102PackageGS15In Commercial Distribution
05707480129119PackageGS110In Commercial Distribution
05707480129096PrimaryGS10
05707480129126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480129102057074801291025707480129102
05707480129119057074801291195707480129119
05707480129096057074801290965707480129096
05707480129126057074801291265707480129126

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
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
305682023
Device count
100
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

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05707480145317SPUR® II Pediatric Resuscitator5316160005316160002020-06-24
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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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