Identity
- Trade Name
- CaStar Cap, 22mm ID FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- BREATHING CIRCUIT, TUBES AND CONNECTORS EUDAMED
- Model / Reference
- STR/019 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08058323016606 EUDAMEDFDA UDI
- Basic UDI-DI
- 80583230DCCIRCUITIMF EUDAMED
- Direct Marketing DI
- 08058323016606 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Straight/elbow breathing circuit connector, single-use
CaStar Cap, 22mm ID by Intersurgical Incorporated — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (2)
- FDA UDI 15a80546-c464-401d-b6c0-cbf41d465e9c 33 fields · synced Jun 18, 2026
- EUDAMED e0d246c8-7edc-4310-9619-6ed743c80d64 61 fields · synced Jun 18, 2026