FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NAR Cricothyrotomy Kit
DI: 00842209121328
·
Model: 10-0048
·
NORTH AMERICAN RESCUE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NAR Cricothyrotomy Kit
- Primary DI
- 00842209121328
- 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
- 2022-01-05
- Public Version
- 3
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- 8b5430e2-3d45-4dfe-9d64-4f0bc6246c74
- Distribution End Date
- 2022-09-30
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OGP | Cricothyrotomy Kit | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45926 | Cricothyrotomy kit, single-use | A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842209121328 | GS1 | ||||
| Package | 10842209121325 | GS1 | Box | 10 | Not in Commercial Distribution | 2022-09-30 |
| Package | 20842209121322 | GS1 | Carton | 10 | Not in Commercial Distribution | 2022-09-30 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8.0 | Millimeter |