Identity
- Trade Name
- RUSCH EZ-Blocker Kit EUDAMEDRUSCH FDA UDI
- Generic Name
- Endobronchial tube FDA UDI
- Device Name
- EZ Blocker Kit EUDAMEDEZ-Blocker(TM) FDA UDI
- Model / Reference
- MG-02770-002 EUDAMEDIPN926248 FDA UDI
- Description
- EZ-Blocker(TM) FDA UDI
Identifiers
- Catalog Number
- MG-02770-002 FDA UDI
- Primary DI / UDI-DI
- 24026704743340 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000256KV EUDAMED
- 510(k) Number
- K121462 FDA UDI
- FDA Product Code
- CBI FDA UDI
- EMDN Code
- R010499 ONE LUNG VENTILATION DEVICES (OLV) - OTHER EUDAMED
- GMDN Term
- Endobronchial tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5740 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endobronchial tube
Rusch by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endobronchial tube.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Human-broncho endobronchial tube — INSUNG MEDICAL Co., Ltd.. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
- Mallinckrodt — Covidien LP · Class II
- Endobronchial Tube — Well Lead Medical Co., Ltd · Class II
- SILBRONCHO (RIGHT LUNG) — Fuji Systems Corp. · Class II
- UNIVENT TUBE (TCB TYPE) — Fuji Systems Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K121462 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI 904f43ce-aaec-4cc3-a80a-34bcc7647a5a 36 fields · synced Aug 1, 2026
- EUDAMED f018fbcf-851f-4cdd-a15d-a96db713631a 61 fields · synced Aug 1, 2026