FDA.report

EFH-7F-W

Primary DI
04035479138295
Brand
EFH-7F-W
Company
BIOTRONIK SE & Co. KG
Model
401012
Catalog number
401012
Published
2014-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DTBpermanent pacemaker Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035479138295PackageGS15In Commercial Distribution
04035479145323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035479138295040354791382954035479138295
04035479145323040354791453234035479145323

GMDN Terms

TermDefinition
Pacing/defibrillation lead suture sleeveA small device with a hollow centre that functions as a channel for a pacing or defibrillation lead(s), and is positioned at the point where the surgeon will suture the lead to the patient's tissue to prevent it from moving after the implantation procedure is completed. It is typically made of a silicone rubber material and is implanted with the pacemaker or defibrillator system.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags

DUNS number
315620229
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

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04035479188399NEO 2401.U/14928174928172024-12-18
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04035479184636Home Monitoring Service Center3.594860922024-01-10
04035479187163Home Monitoring Service Center3.614906882024-09-03
04035479186005NEO2401.U4883722024-06-17
04035479186012PSW2401.U4883732024-06-17
04035479052515PK-222 US/2,8m3352813352812014-08-20
04035479186128Home Monitoring Service Center3.604886702024-05-29

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