FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756039550
·
Model: 83-000067
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756039550
- Version / Model
- 83-000067
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- bb24e96f-0e1d-4331-8fc8-cdb6f826dd40
Device Description
ST Yankauer Standard Tip
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOL | CATHETER AND TIP, SUCTION | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46562 | Airway emergency clearance/suction tube | A device intended to be used in an emergency to remove an airflow-obstructing object or material in the oropharynx, trachea, or bronchi to prevent patient asphyxiation. It is typically in the form of a long vacuum tube capable of being inserted into the airway to aspirate fluids or solid objects when suction is applied. It may be used by emergency medical services (EMS). This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756039555 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 00749756039550 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]