Model: FGS-15-773
Catalog: FGS-15-773
DI: 00860002238500
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Nav+ Guidance Set (10-Pack)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
245b17ed-1b6b-4363-af4c-fd13d92e2f56
Distribution Status:
In Commercial Distribution
DUNS Number:
116996235
Device Count:
10
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00860002238593
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860002238500
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61729
Name: Central venous catheter navigation system support kit
Definition:
A collection of sterile, noninvasive devices intended to assist use of a central venous catheter navigation system during electrocardiographic (ECG) supported guidance and positioning of a central venous catheter. The kit is dedicated to ECG-supported catheter navigation and typically includes system components (e.g., ECG leads, connectors) and other supportive devices (e.g., cable cover). The kit is intended to support the procedure which involves the catheter used as an intravascular electrode whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data. This is a single-use device.
FDA Product Codes
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
DRX
Electrode, Electrocardiograph
NGT
Saline, Vascular Access Flush
Premarket Submissions
Submission Number:
K243484
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
10
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
38
Storage Handling - Storage Handling Type:
Storage Environment Temperature