FDA UDI
In Commercial Distribution
🇺🇸 United States
Forsure
DI: 00815123012836
·
Model: 11150090
·
FORSURE MEDICAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Forsure
- Primary DI
- 00815123012836
- Version / Model
- 11150090
- Catalog Number
- 11150090
- Company Name
- FORSURE MEDICAL PRODUCTS LLC
- Labeler DUNS
- 033809722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-13
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f6dd3a66-dde7-4f6e-a74d-b1202458992d
Device Description
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
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
- No
- 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
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42424 | Oropharyngeal airway, single-use | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815123012830 | GS1 | MASTER CASE | 45 | In Commercial Distribution | |
| Package | 10815123012833 | GS1 | INNER BOX | 10 | In Commercial Distribution | |
| Primary | 00815123012836 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 90 MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN CLEAN DRY CONDITIONS AWAY FROM HEAT AND LIGHT