Identity
- Trade Name
- DAR FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- Saline Vial 0.9% Sodium Chloride Solution for Irrigation FDA UDI
- Model / Reference
- 444SPA0000 FDA UDI
- Description
- Saline Vial 0.9% Sodium Chloride Solution for Irrigation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521812352 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDI
Category: Suction system catheter, general-purpose
Dar by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suction system catheter, general-purpose.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI ceabec2a-f68f-46e2-9246-b13d8c8feae1 35 fields · synced Jun 8, 2026