FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NAR Tracheostomy Kit
DI: 00842209107315
·
Model: 10-0048
·
NORTH AMERICAN RESCUE, LLC
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NAR Tracheostomy Kit
- Primary DI
- 00842209107315
- Version / Model
- 10-0048
- Catalog Number
- 10-0048
- Company Name
- NORTH AMERICAN RESCUE, LLC
- Labeler DUNS
- 832426782
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 3
- Public Version Date
- 2022-03-17
- Public Version Status
- Update
- Public Device Record Key
- 344faaad-9b8e-49db-97a6-c1893ad85015
- Distribution End Date
- 2022-03-01
Device Description
TRACHEAL TUBE - CUFFED 6.0mm ID w' BOUGIE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35404 | Tracheostomy tube, non-reinforced, non-customized, single-use | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842209107315 | GS1 | ||||
| Package | 10842209107312 | GS1 | box | 10 | Not in Commercial Distribution | 2022-03-01 |
| Package | 20842209107319 | GS1 | carton | 10 | Not in Commercial Distribution | 2022-03-01 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8.0 | Millimeter |