FDA UDI
In Commercial Distribution
🇺🇸 United States
CORFLO Gastrostomy Tube
DI: 10815149021024
·
Model: 52-0516
·
CORPAK MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CORFLO Gastrostomy Tube
- Primary DI
- 10815149021024
- Version / Model
- 52-0516
- Catalog Number
- 52-0516
- Company Name
- CORPAK MEDSYSTEMS, INC.
- Labeler DUNS
- 147530323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-24
- Public Version
- 4
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 2a218048-7f0c-4e5b-b977-a3ecb6924d97
Device Description
Dual Gastrostomy tube with ENFit Connectors
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
- Yes
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 35419 | Gastrostomy tube | A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815149021021 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 10815149021024 | GS1 |
Customer Contacts
- Phone
- +1(847)403-3400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French | |
| Total Volume | 5 | Milliliter | |
| Device Size Text, specify | 16 FR (5.3mm) X 5cc |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No