FDA UDI
In Commercial Distribution
🇺🇸 United States
BALLARD™
DI: 10889483563274
·
Model: 12241
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- BALLARD™
- Primary DI
- 10889483563274
- Version / Model
- 12241
- Catalog Number
- 12241
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-17
- Public Version
- 2
- Public Version Date
- 2026-01-16
- Public Version Status
- Update
- Public Device Record Key
- 972793dc-d7ac-4e0f-ba81-a969a3bbb08a
Device Description
BALLARD™ ORAL CARE SWAB, Bulk Packed
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
- Yes
- 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 |
|---|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45172 | Oral care kit, single-use | A collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483563278 | GS1 | Case | 2 | In Commercial Distribution | |
| Primary | 10889483563274 | GS1 | ||||
| Previous | 00609038968704 | GS1 | ||||
| Package | 20889483563271 | GS1 | Dispenser | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]