Identity
- Trade Name
- GYRUS ACMI FDA UDI
- Generic Name
- Tympanostomy tube FDA UDI
- Device Name
- BAXTER BUTTON VENT TUBE ADULT 1.27MM ID FLUOROPLASTIC PACIFIC FDA UDI
- Model / Reference
- 70140270 FDA UDI
- Description
- BAXTER BUTTON VENT TUBE ADULT 1.27MM ID FLUOROPLASTIC PACIFIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925039636 FDA UDI
- 510(k) Number
- K000801 FDA UDI
- FDA Product Code
- ETD FDA UDI
- GMDN Term
- Tympanostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Category: Tympanostomy tube
Gyrus Acmi by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tympanostomy tube.
- Sheehy — MEDTRONIC XOMED, INC. · Class II
- SHEA PARASOL VENT TUBE W/TAB — Grace Medical, Inc. · Class II
- NeoZoline — ADEPT MEDICAL LIMITED · Class II
- DONALDSON VENT TUBE — Grace Medical, Inc. · Class II
- NeoZoline — ADEPT MEDICAL LIMITED · Class II
- NeoZoline — JEDMED Instrument Company · Class II
- TINY TRIUNE VENT TUBE — Grace Medical, Inc. · Class II
- TINY TRIUNE VENT TUBE — Grace Medical, Inc. · Class II
Cleared under the same submission
K000801 also covers:
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 2000732a-1ef4-46a4-9c02-e5ee6ece896f 35 fields · synced Jun 6, 2026