DEVICE: SJM™ (05414734023979)

Download: XML | JSON

Device Identifier (DI) Information

SJM™
406300
406300
ST. JUDE MEDICAL, INC.
05414734023979
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
Haemostasis valve A sterile, noninvasive device with a self-sealing lumen (valve) designed as a conduit through which a small diameter diagnostic/interventional device (e.g., 25 French or less) can be introduced into or withdrawn from the patient's vasculature while maintaining haemostasis to reduce blood loss from the patient. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer, torque device). 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 A COOL, DARK, DRY PLACE.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 9 French
CLOSE

Device Status

In Commercial Distribution
April 30, 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
15414734023976 5 05414734023979 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