Identity
- Trade Name
- ASP AEROFLEX FDA UDI
- Generic Name
- Endoscope channel-opening adaptor FDA UDI
- Device Name
- Leak Tester Connection Tube FDA UDI
- Model / Reference
- 9119011 FDA UDI
- Description
- Leak Tester Connection Tube FDA UDI
Identifiers
- Catalog Number
- 9119011 FDA UDI
- Primary DI / UDI-DI
- 10705037064670 FDA UDI
- 510(k) Number
- K181472 FDA UDI
- FDA Product Code
- FEB FDA UDI
- GMDN Term
- Endoscope channel-opening adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope channel-opening adaptor
Asp Aeroflex by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope channel-opening adaptor.
- PENTAX Medical — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- PENTAX — HOYA CORPORATION · Class II
- Evotech — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Evotech — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Evotech — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
- Evotech — ADVANCED STERILIZATION PRODUCTS SERVICES INC. · Class II
Cleared under the same submission
K181472 also covers:
- ASP AERO-OPA — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ASP AEROFLEX — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- AUTOSURE — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
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 |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI a8a321ee-d2c1-4f8d-8c3e-ae284ea3c33f 37 fields · synced May 31, 2026