FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline Industries
DI: 10080196837892
·
Model: DYND70316
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline Industries
- Primary DI
- 10080196837892
- Version / Model
- DYND70316
- Catalog Number
- DYND70316
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 3
- Public Version Date
- 2019-12-23
- Public Version Status
- Update
- Public Device Record Key
- fbf6d310-e749-4fd3-a630-2cc7aab3d9c6
Device Description
TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/CS
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58891 | Gastrostomy tube Y-piece connector | A connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. It has two resealable ports intended for flushing the line and/or administering medications without the need for tube disconnection or interruption of an enteral feed. It is typically made of plastic materials and is available in a range of sizes. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50080196837890 | GS1 | MASTER CARTON | 10 | In Commercial Distribution | |
| Primary | 10080196837892 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15 CUBIC CENTIMETERS IN VOLUME; 16 FRENCH |