FDA UDI
In Commercial Distribution
🇺🇸 United States
NAR TACTICAL SUCTION DEVICE
DI: 00842209109463
·
Model: 10-0018
·
NORTH AMERICAN RESCUE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NAR TACTICAL SUCTION DEVICE
- Primary DI
- 00842209109463
- Version / Model
- 10-0018
- Catalog Number
- 10-0018
- Company Name
- NORTH AMERICAN RESCUE, LLC
- Labeler DUNS
- 832426782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-12
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 465287c1-eee8-46c2-9815-04c2aefc7741
Device Description
KIT, SUCTION DEVICE, TACTICAL HAND HELD
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47368 | Emergency airway clearance suction system, manual | A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842209109463 | GS1 | ||||
| Package | 10842209109460 | GS1 | Box | 50 | In Commercial Distribution |