FDA UDI
In Commercial Distribution
🇺🇸 United States
ACU 1060.2 Transtracheal Catheter
DI: M996ACU106020
·
Model: ACU 1060.2
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACU 1060.2 Transtracheal Catheter
- Primary DI
- M996ACU106020
- Version / Model
- ACU 1060.2
- Catalog Number
- ACU 1060.2
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-13
- Public Version
- 1
- Public Version Date
- 2021-01-21
- Public Version Status
- New
- Public Device Record Key
- c422504f-e6b0-44be-9a81-94dfe3d31dd7
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36231 | Oxygen administration transtracheal catheter | A flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996ACU106020 | HIBCC |
Customer Contacts
- Phone
- 4128541133
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955461 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 14 | Gauge |