FDA.report

N/A

Primary DI
10841898129704
Brand
N/A
Company
INNOVATIVE HEALTH LLC
Model
N/A
Catalog number
F5ADP282CT
Device description
Webster Fixed Curve w/Auto ID Diagnostic EP Catheter 5F
Published
2020-01-10
Public version status
New
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
NLHCatheter, Recording, Electrode, Reprocessed

Product Code Classifications

CodeDeviceSpecialtyClass
NLHCatheter, Recording, Electrode, ReprocessedCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841898129704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084189812970410841898129704

GMDN Terms

TermDefinition
Cardiac mapping catheter, percutaneous, reprocessedA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias and cardioversion (CV), and electrophysiology (EP) mapping. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
877-400-3740regulatory@innovative-health.com

Regulatory Flags

DUNS number
015575953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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10841898113451N/AN/A4013062017-03-14
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10841898113499N/AN/A4013082018-08-21
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10841898113529N/AN/A4013532017-03-14
10841898113567N/AN/A4012712018-08-21
10841898113611N/AN/A4012262017-10-16
10841898113635N/AN/A4012272017-03-14

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