FDA.report

ECG ESU block, 5-lead

Primary DI
04049098008020
Brand
ECG ESU block, 5-lead
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
5947226
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications

CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049098008020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049098008020040490980080204049098008020

GMDN Terms

TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004372437info@draeger.com

Regulatory Flags

DUNS number
788289952
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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