FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651136760
·
Model: 13676
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651136760
- Version / Model
- 13676
- Catalog Number
- P400X4D
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 4
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- 598ed0f5-95ba-4b97-b8ca-a645625952b2
Device Description
HALYARD* ON-Q* Pump Fixed Flow-400 ml -4 ml/hr (dual; 2 ml/site)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEB | PUMP, INFUSION, ELASTOMERIC | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46542 | Elastomeric infusion pump system | An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651136764 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10680651136760 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063530 | 000 |