DEVICE: Fast-Cath™ (05414734203814)

Download: XML | JSON

Device Identifier (DI) Information

Fast-Cath™
Duo
406301
ST. JUDE MEDICAL, INC.
05414734203814
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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, 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
DYB INTRODUCER, CATHETER
CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 12 French
CLOSE

Device Status

In Commercial Distribution
April 15, 2015

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
15414734203811 5 05414734203814 In Commercial Distribution
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

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE