FDA UDI
In Commercial Distribution
🇺🇸 United States
BALLARD™
DI: 10889483563199
·
Model: 118
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BALLARD™
- Primary DI
- 10889483563199
- Version / Model
- 118
- Catalog Number
- 118
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- b4e31167-564a-4417-b68b-df647bfcd073
Device Description
BALLARD™ SINGLE DOSE VIALS For Airway Lavage and Closed Suction Catheter Cleaning • Pink Vials • 0.9% Sodium Chloride Solution
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
- 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 |
|---|---|---|---|---|
| 35913 | Device-irrigation sterile saline solution | A sterile sodium chloride (NaCl) solution intended to be used for the cleaning and irrigation of a variety of devices that hold or conduct materials (e.g., a Foley catheter or a tracheobronchial suction catheter); it is not dedicated to a particular type of device. The solution is not intended for wound irrigation or injection or intravenous (IV) administration. It is usually available in a plastic container (e.g., 250 ml) or bottle of various sizes. 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 | 20889483563196 | GS1 | Dispenser | 24 | In Commercial Distribution | |
| Primary | 10889483563199 | GS1 | ||||
| Package | 30889483563193 | GS1 | Case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]