DEVICE: V-Cath (B33950530030)

Device Identifier (DI) Information

V-Cath
5053-003
In Commercial Distribution
5053-003
NEO MEDICAL INC.
B33950530030
HIBCC

1
015510540 *Terms of Use
5.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
CLOSE

Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular catheter introduction set A 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KZH Introducer, Syringe Needle
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K951384 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Away From Sunlight
Special Storage Condition, Specify: Keep Dry
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 10.0 Centimeter
Catheter Gauge: 5.0 French
CLOSE

Device Record Status

4b3a9833-81ac-49e9-b497-98b467add9f3
July 06, 2018
3
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B33950530035 10 B33950530030 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
888-450-3334
support@neomedicalinc.com
CLOSE