FDA.reportPublic FDA data

Prytime Medical Devices, Inc.

Primary DI
00863092000101
Brand
Prytime Medical Devices, Inc.
Company
Prytime Medical Devices, Inc.
Model
KT1835C
Device description
REBOA Catheter Convenience Set
Published
2022-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFCCatheter Introducer Kit
PXBPercutaneous Introducer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFCCatheter Introducer KitCardiovascular2
PXBPercutaneous Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863092000101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863092000101008630920001018630920001010863092000101

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00excursions permitted to 15-30 degree C (59-86F); do not freeze
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050741500
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00850001105057Prytime Medical Devices Inc.ER7232PLUS2022-12-15
00850001105064Prytime Medical Devices, Inc.PRP7226PRO2022-12-15
00863092000118ER-REBOA CatheterER7232AER7232A2018-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956349537CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
50198956349535CARDINAL HEALTHCardinal Health 200, LLCOFC2026-02-20
00850001105125Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.OFC2024-10-16
B090LRKIT0Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.PXB2024-04-24
B090LRKIT0Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
B090LRKIT1Landmark Catheter Introducer KitZIEN MEDICAL TECHNOLOGIES, INC.OFC2024-04-24
10197106407257CARDINAL HEALTHCardinal Health 200, LLCPXB2023-08-11
50197106407255CARDINAL HEALTHCardinal Health 200, LLCPXB2023-08-11
10197106114018CARDINAL HEALTHCardinal Health 200, LLCPXB2023-02-07
50197106114016CARDINAL HEALTHCardinal Health 200, LLCPXB2023-02-07
10197106117118CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
50197106117116CARDINAL HEALTHCardinal Health 200, LLCOFC2023-02-03
10197106093665CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-09
10197106080092CARDINAL HEALTHCardinal Health 200, LLCOFC2023-01-03
10195594801823CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
50195594801821CARDINAL HEALTHCardinal Health 200, LLCOFC2022-11-09
10195594759643CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
50195594759641CARDINAL HEALTHCardinal Health 200, LLCOFC2022-07-25
10195594498221CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
50195594498229CARDINAL HEALTHCardinal Health 200, LLCOFC2022-01-04
10195594958237CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
50195594958235CARDINAL HEALTHCardinal Health 200, LLCOFC2021-03-08
10195594926137CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
50195594926135CARDINAL HEALTHCardinal Health 200, LLCOFC2021-02-11
10888439821550CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
50888439821558CARDINAL HEALTHCardinal Health 200, LLCOFC2020-04-24
10888439783827CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
50888439783825CARDINAL HEALTHCardinal Health 200, LLCOFC2020-03-24
10888439448115CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08
50888439448113CARDINAL HEALTHCardinal Health 200, LLCOFC2019-04-08