FDA UDI
In Commercial Distribution
🇺🇸 United States
CORFLO PEG Kit with snare
DI: 10815149021444
·
Model: 50-4020-S7
·
CORPAK MEDSYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CORFLO PEG Kit with snare
- Primary DI
- 10815149021444
- Version / Model
- 50-4020-S7
- Catalog Number
- 50-4020-S7
- Company Name
- CORPAK MEDSYSTEMS, INC.
- Labeler DUNS
- 147530323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 3
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 2510dfbc-3366-436e-ae8c-0da4cd9be728
Device Description
PEG Kit with ENFit connectors Push Technique; with snare
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 35149 | Ultraviolet phototherapy unit, professional | A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20815149021441 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 10815149021444 | GS1 |
Customer Contacts
- Phone
- +1(847)403-3400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20 FR (6.7mm) | ||
| Catheter Gauge | 20 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No