Identity
- Trade Name
- BALLARD FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Device Name
- Suction Valve and Y-Adapter FDA UDI
- Model / Reference
- 96899 FDA UDI
- Description
- Suction Valve and Y-Adapter FDA UDI
Identifiers
- Catalog Number
- 12606 FDA UDI
- Primary DI / UDI-DI
- 00609038968995 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 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 kit, single-use
Ballard by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral care kit, single-use.
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class II
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
- Plak-Vac — TRADEMARK MEDICAL, L.L.C. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 558d498f-27c1-40d0-b1d0-7618dad961ae 35 fields · synced Jun 9, 2026