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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAY | SUPPORT, BREATHING TUBE | Anesthesiology | 868.5280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63438 | Tracheostomy tube neck holder, single-use | A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019517382482 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 15019517382488 | GS1 |