Identity
- Trade Name
- Ballard* Closed Suction System FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- BALLARD* Closed Suction Catheter, Elbow, WET PAK*, Neonatal/Pediatric FDA UDI
- Model / Reference
- 99571 FDA UDI
- Description
- BALLARD* Closed Suction Catheter, Elbow, WET PAK*, Neonatal/Pediatric FDA UDI
Identifiers
- Catalog Number
- 8295J FDA UDI
- Primary DI / UDI-DI
- 00609038995717 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Suction system catheter, general-purpose 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
Category: Suction system catheter, general-purpose
Ballard* Closed Suction System by Avanos Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI b337f66c-d2ae-41c5-9d21-c3e3b3ec30b6 36 fields · synced Jun 9, 2026