Identity
- Trade Name
- PF 1010 Straight Silicone Rubber Connector FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, reusable FDA UDI
- Device Name
- Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable. FDA UDI
- Model / Reference
- PF 1010 FDA UDI
- Description
- Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable. FDA UDI
Identifiers
- Catalog Number
- PF 1010 FDA UDI
- Primary DI / UDI-DI
- M996PF10100 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Straight/elbow breathing circuit connector, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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: Straight/elbow breathing circuit connector, reusable
PF 1010 Straight Silicone Rubber Connector 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 b4159384-796a-405c-9445-85ab3900d716 35 fields · synced Jun 1, 2026