Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- Cuff pressure gauge FDA UDI
- Model / Reference
- IPN041642 FDA UDI
- Description
- Cuff pressure gauge FDA UDI
Identifiers
- Catalog Number
- 112700-000000 FDA UDI
- Primary DI / UDI-DI
- 24026704008548 FDA UDI
- 510(k) Number
- K951046 FDA UDI
- FDA Product Code
- BSK FDA UDI
- GMDN Term
- Endotracheal tube cuff inflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5750 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
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Endotracheal tube cuff inflator
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube cuff inflator.
- Venner™ Tracheal Seal Monitor — VENNER MEDICAL (SINGAPORE) PTE. LTD. · Class II
- Cuffix — Biovo Technologies , Ltd. · Class II
- AincA® — Anesthesia Associates, Inc. · Class II
- IntelliCuff — HAMILTON MEDICAL, INC. · Class II
- TRACOE technic — Tracoe medical GmbH · Class II
- Ambu A/S — VBM Medizintechnik GmbH · Class II
- AG Cuffill Kruuse - VET — HOSPITECH RESPIRATION LTD · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K951046 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
- Teleflex Incorporated
Sources (1)
- FDA UDI 2e551caf-e7f4-42ef-abfe-f14324753524 36 fields · synced May 30, 2026