Identity
- Trade Name
- BALLARD FDA UDI
- Generic Name
- Oral care swab FDA UDI
- Device Name
- Oral Care Suction Swab FDA UDI
- Model / Reference
- 96897 FDA UDI
- Description
- Oral Care Suction Swab FDA UDI
Identifiers
- Catalog Number
- 12603 FDA UDI
- Primary DI / UDI-DI
- 00609038968971 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Oral care swab FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral care swab
Ballard by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral care swab.
- Q-Care — SAGE PRODUCTS LLC · Class I
- Q-Care — SAGE PRODUCTS LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Toothette Oral Care — SAGE PRODUCTS LLC · Class II
- Q-Care — SAGE PRODUCTS LLC · Class I
- Q-Care — SAGE PRODUCTS LLC · Class II
- Sage — SAGE PRODUCTS LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 96277bbe-a212-4db8-8103-37603ee566de 35 fields · synced Jun 9, 2026