Device
CL25313 Custom Med Label Pack
Manufacturer
XODUS MEDICAL, INC.
Model: CL25313 Catalog: CL25313 DI: 00787551041446 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
CL25313 Custom Med Label Pack
Sterilization
Method Types - Sterilization Method: Radiation Sterilization
Device Sterile: Yes
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ee414d46-e932-4e8e-aa03-da96e7106686
Distribution Status: In Commercial Distribution
DUNS Number: 868042664
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: CASE
Item #1 - Device ID: 20787551041440
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 100
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00787551041446
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00787551041446
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 47731
Name: Procedural medication labelling set
Definition:
A collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.
FDA Product Codes
LYV
LABEL OR TAG, STERILE