Identity
- Trade Name
- Ballard* Manual Percussor FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- Ballard* Manual Percussor for Neonates FDA UDI
- Model / Reference
- 96867 FDA UDI
- Description
- Ballard* Manual Percussor for Neonates FDA UDI
Identifiers
- Catalog Number
- 11000 FDA UDI
- Primary DI / UDI-DI
- 00609038968674 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suction system catheter, general-purpose
Ballard* Manual Percussor by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction system catheter, general-purpose.
- Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class II
- Gen2 — SURGIX MEDICAL LLC · Class II
- Hayden Medical — Hayden Medical Inc · Class II
- Gen2 — SURGIX MEDICAL LLC · Class II
- GP General Purpose Drainage Catheter — Uresil Corp. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- Gen2 — SURGIX MEDICAL LLC · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 24bc6ce5-4c87-4b6b-8cad-a418682643ec 35 fields · synced Jun 9, 2026