FDA UDI
In Commercial Distribution
🇺🇸 United States
BALLARD™
DI: 10889483563113
·
Model: 11000
·
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
- 10889483563113
- Version / Model
- 11000
- Catalog Number
- 11000
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-01
- Public Version
- 1
- Public Version Date
- 2025-12-09
- Public Version Status
- New
- Public Device Record Key
- ec308e88-4ed5-4677-808d-239fc4fb4961
Device Description
BALLARD™ MANUAL PERCUSSOR FOR NEONATES
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30889483563117 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10889483563113 | GS1 | ||||
| Previous | 00609038968674 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]