Prytime Medical Devices, Inc.

GUDID 00850001105125

REBOA Catheter Compass Convenience Set

Prytime Medical Devices, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID00850001105125
NIH Device Record Keye7d7bfd8-6706-47b8-9a68-ec297451024b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrytime Medical Devices, Inc.
Version Model NumberKT1835M
Company DUNS050741500
Company NamePrytime Medical Devices, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *excursions permitted to 15-30 degree C (59-86F); do not freeze

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001105125 [Primary]

FDA Product Code

OFCCatheter Introducer Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-24
Device Publish Date2024-10-16

On-Brand Devices [Prytime Medical Devices, Inc.]

00863092000101REBOA Catheter Convenience Set
00850001105064pREBOA-PRO Balloon Occlusion Catheter
00850001105125REBOA Catheter Compass Convenience Set

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