Identity
- Trade Name
- ACU 1060.2 Transtracheal Catheter FDA UDI
- Generic Name
- Oxygen administration transtracheal catheter FDA UDI
- Device Name
- ACU 1060.2 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration. Needle size: 14Gauge / Child RX only. FDA UDI
- Model / Reference
- ACU 1060.2 FDA UDI
- Description
- ACU 1060.2 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration. Needle size: 14Gauge / Child RX only. FDA UDI
Identifiers
- Catalog Number
- ACU 1060.2 FDA UDI
- Primary DI / UDI-DI
- M996ACU106020 FDA UDI
- 510(k) Number
- K955461 FDA UDI
- FDA Product Code
- BTO FDA UDI
- GMDN Term
- Oxygen administration transtracheal catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDI
Category: Oxygen administration transtracheal catheter
ACU 1060.2 Transtracheal Catheter by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Oxygen administration transtracheal catheter.
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Cleared under the same submission
K955461 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 |
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Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI c422504f-e6b0-44be-9a81-94dfe3d31dd7 37 fields · synced May 30, 2026