FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical, Inc.

DI: 15019517382488 · Model: 011-520000 · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical, Inc.
Primary DI
15019517382488
Version / Model
011-520000
Company Name
ICU MEDICAL, INC.
Labeler DUNS
118380146
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-06
Public Version
1
Public Version Date
2026-04-14
Public Version Status
New
Public Device Record Key
eb61cbe6-e700-4d46-b135-3ddc78b8cdf2

Device Description

GTIN for 011-520000, 1/EA

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JAY SUPPORT, BREATHING TUBE

GMDN Terms

Code Name
63438 Tracheostomy tube neck holder, single-use

Identifiers

Type ID
Package 35019517382482
Primary 15019517382488