FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 30080196035575
·
Model: DYND60603
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Medline
- Primary DI
- 30080196035575
- Version / Model
- DYND60603
- Catalog Number
- DYND60603
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-01-27
- Public Version
- 2
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 9acfea65-7a83-49dc-8fb9-3859b5c4fe10
Device Description
60MM,BLACK,GUEDEL AIRWAY
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
- No
- 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 |
|---|---|---|---|---|
| 65172 | Intravenous pressure infusor, manual, single-use | A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a single-use device. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10080196035571 | GS1 | ||||
| Primary | 30080196035575 | GS1 | ||||
| Package | 50080196035579 | GS1 | MC | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry