Identity
- Trade Name
- DS 7-45 Bronchoscope Swivel FDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Device Name
- DS 7-45 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x 15mm OD (equipment port). Fits components of adult ventilator circuits. Includes one thermoplastic rubber cap; cap allows for the use of a suctioning catheter or fiber-optic bronchoscope without significant loss of PEEP. Single-Patient Use. FDA UDI
- Model / Reference
- DS 7-45 FDA UDI
- Description
- DS 7-45 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x 15mm OD (equipment port). Fits components of adult ventilator circuits. Includes one thermoplastic rubber cap; cap allows for the use of a suctioning catheter or fiber-optic bronchoscope without significant loss of PEEP. Single-Patient Use. FDA UDI
Identifiers
- Catalog Number
- DS 7-45 FDA UDI
- Primary DI / UDI-DI
- M996DS7450 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 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
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, single-use
DS 7-45 Bronchoscope Swivel 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 67f90b97-b4c9-4745-80f7-8617bd111401 35 fields · synced May 30, 2026