FDA UDI
In Commercial Distribution
🇺🇸 United States
SunMed
DI: 20889483000776
·
Model: 1-1521-06
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SunMed
- Primary DI
- 20889483000776
- Version / Model
- 1-1521-06
- Catalog Number
- 1-1521-06
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-21
- Public Version
- 1
- Public Version Date
- 2023-03-29
- Public Version Status
- New
- Public Device Record Key
- 665b13d4-10a2-4b54-a8b4-aa9538b17ccf
Device Description
GUEDEL PVC SZ6 ORNGE 110mm P50
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
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 |
|---|---|---|---|---|---|---|
| Primary | 20889483000776 | GS1 |
Customer Contacts
- Phone
- +1(800)433-2797
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 110 | Millimeter |