Prytime Medical Devices, Inc.

Primary DI
00850001105064
Brand
Prytime Medical Devices, Inc.
Company
Prytime Medical Devices, Inc.
Model
PRP7226PRO
Device description
pREBOA-PRO Balloon Occlusion Catheter
Published
2022-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
DQYCatheter, Percutaneous
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DQYCatheter, PercutaneousCardiovascular2
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200459000pREBOA-PRO CatheterPrytime Medical Devices, Inc.2020-06-03MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001105064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001105064008500011050648500011050640850001105064

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050741500
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001105118Prytime Medical Devices, Inc.PRP7226M2025-06-20
00850001105125Prytime Medical Devices, Inc.KT1835M2024-10-16
00863092000101Prytime Medical Devices, Inc.KT1835C2022-12-15
00850001105057Prytime Medical Devices Inc.ER7232PLUS2022-12-15
00863092000118ER-REBOA CatheterER7232AER7232A2018-07-15

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