FDA.report

HexaFlow™ Irrigation Pump

Primary DI
00763000871895
Brand
HexaFlow™ Irrigation Pump
Company
MEDTRONIC, INC.
Model
AFR-00005
Device description
IRRIGATION PUMP AFR-00005 HEXAFLOW US
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OAECatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Product Code Classifications

CodeDeviceSpecialtyClass
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationUnknown3

Premarket Submissions

SubmissionSupplement
P240013000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P2400130001969-12-31

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000871895PrimaryGS10

GMDN Terms

TermDefinition
Basic roller pumpA mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

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