FDA UDI
In Commercial Distribution
🇺🇸 United States
BALLARD™
DI: 10889483563380
·
Model: 123
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- BALLARD™
- Primary DI
- 10889483563380
- Version / Model
- 123
- Catalog Number
- 123
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-12-01
- Public Version
- 2
- Public Version Date
- 2026-01-16
- Public Version Status
- Update
- Public Device Record Key
- 496b1d50-5e74-492e-bc3e-c16264cffc98
Device Description
BALLARD™ READY CARE™ ORAL CARE SUCTION PROBES
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
- 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 |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10749 | Airway suction catheter | A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483563384 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 10889483563380 | GS1 | ||||
| Previous | 00609038938103 | GS1 | ||||
| Unit of Use | 00889483563383 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]