FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 20680651938040
·
Model: 93804
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
24
Basic Information
- Brand Name
- Halyard
- Primary DI
- 20680651938040
- Version / Model
- 93804
- Catalog Number
- 116
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2017-01-09
- Public Version
- 3
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- 5f071363-a2aa-4c86-ba31-9fca5bc7f537
Device Description
HALYARD* Saline Vials for Closed Suction Catheters-Inhalation USP
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44746 | Inhalation therapy saline solution, isotonic | A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651938047 | GS1 | CS | 6 | In Commercial Distribution | |
| Primary | 20680651938040 | GS1 | ||||
| Unit of Use | 90680651938049 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]