FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 20680651366003
·
Model: 36600
·
O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Halyard
- Primary DI
- 20680651366003
- Version / Model
- 36600
- Catalog Number
- 36600
- Company Name
- O&M HALYARD, INC.
- Labeler DUNS
- 081057389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 1
- Public Version Date
- 2020-11-26
- Public Version Status
- New
- Public Device Record Key
- fe5d9a58-2b67-4b48-8721-fd620bf00bf1
Device Description
HALYARD* Catheter Leg Strap
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ILH | SPLINT, HAND, AND COMPONENTS | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61139 | Arm procedure positioner, single-use | A device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651366000 | GS1 | CS | 4 | In Commercial Distribution | |
| Primary | 20680651366003 | GS1 | ||||
| Unit of Use | 90680651366002 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]