FloProbe 3/8’’ x 3/8” (Non Sterile)

Primary DI
10814321020176
Brand
FloProbe 3/8’’ x 3/8” (Non Sterile)
Company
Movair, Inc.
Model
3080N
Device description
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Published
2016-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DPTProbe, Blood-Flow, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPTProbe, Blood-Flow, ExtravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963703000ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)International Biophysics Corp.1998-04-08DPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814321020176PrimaryGS10
00814321020179Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081432102017610814321020176
00814321020179008143210201798143210201790814321020179

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic blood flowmeterA device using electromagnetic (EM) technology to provide a method of confirming and measuring the velocity of blood flow in vessels after coronary artery bypass, organ transplant, and other vascular reconstructive surgery. It uses an invasive technique that is performed with either a catheter inserted into a vessel or with a probe that surrounds a surgically exposed vessel without penetrating the vessel wall. Also known as an EM flowmeter.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
788403103
Device count
10
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013561406MPVMV50012025-03-12
00860013561413MPVMV50002025-03-12
10814321020152"FloProbe 1/4’’ x 1/4"" (Non Sterile)"3090N2016-07-12
10814321020213IBC Aortic Punch, Long, 2.8mmAPL282016-08-02
10814321020220IBC Aortic Punch, Long, 3.6mmAPL36 2016-08-02
10814321020237IBC Aortic Punch, Long, 4.0mmAPL402016-08-02
10814321020244IBC Aortic Punch, Long, 4.4mmAPL442016-08-02
10814321020251IBC Aortic Punch, Long, 4.8mmAPL482016-08-02
10814321020268IBC Aortic Punch, Long, 5.2mmAPL522016-08-02
10814321020275IBC Aortic Punch, Long, 5.6mmAPL562016-08-02
10814321020282IBC Aortic Punch, Long, 6.0mmAPL602016-08-02
10814321020299IBC Aortic Punch, Medium, 2.8mmAPM282016-08-02
10814321020305IBC Aortic Punch, Medium, 3.6mmAPM362016-08-02
10814321020312IBC Aortic Punch, Medium, 4.0mmAPM402016-08-02
10814321020329IBC Aortic Punch, Medium, 4.4mmAPM442016-08-02
10814321020336IBC Aortic Punch, Medium, 4.8mmAPM482016-08-02
10814321020343IBC Aortic Punch, Medium, 5.2mmAPM522016-08-02
10814321020350IBC Aortic Punch, Medium, 5.6mmAPM562016-08-02
10814321020367IBC Aortic Punch, Medium, 6.0mmAPM602016-08-02
00814321020438FloPump6500S6500S2021-03-12

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