Identity
- Trade Name
- enspire FDA UDI
- Generic Name
- Endoscope washer-disinfector (chemical) FDA UDI
- Device Name
- The enspire 300 Series Automated Endoscope Reprocessor 480V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes. FDA UDI
- Model / Reference
- enspire 300 Series FDA UDI
- Description
- The enspire 300 Series Automated Endoscope Reprocessor 480V, Non-vented, Wall Drain is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes. FDA UDI
Identifiers
- Catalog Number
- ENHLD300480NVWD FDA UDI
- Primary DI / UDI-DI
- 00724995217501 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Endoscope washer-disinfector (chemical) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope washer-disinfector (chemical)
enspire by Corporation Steris Canada — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscope washer-disinfector (chemical).
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Cleared under the same submission
K230560 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corporation Steris Canada
Sources (1)
- FDA UDI f34d0bd6-859d-4871-9038-e8c4ea3fada6 36 fields · synced May 30, 2026