Model: Initial Release
Catalog: K13-05712
DI: 00884450467541
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e8de3465-67b4-4e2a-a044-1d90b31a207b
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
20884450467545
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
4
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10884450467548
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10884450467548
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
25
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00884450467541
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00884450467541
Item #3 - Device ID Type:
Primary
Item #3 - 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
PYB
Minor surgical procedures tray