Identity
- Trade Name
- SG 066-2N 1 liter latex-free reservoir bag FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- The SG 066-2N 1 liter latex-free reservoir bag is intended to be used with the SG 066 Oxygen Enrichment Kit, while in use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway. FDA UDI
- Model / Reference
- SG 066-2N FDA UDI
- Description
- The SG 066-2N 1 liter latex-free reservoir bag is intended to be used with the SG 066 Oxygen Enrichment Kit, while in use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996SG0662N0 FDA UDI
- FDA Product Code
- BTC FDA UDI
- GMDN Term
- Breathing circuit bag, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5320 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
No
FDA UDI
Category: Breathing circuit bag, single-use
SG 066-2N 1 liter latex-free reservoir bag by Instrumentation Industries, Incorporated — 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
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI 4ce410a3-4f81-4c87-ad13-c27370d47fa7 34 fields · synced May 30, 2026