FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoMagic
DI: B339307616080
·
Model: 3076-1608
·
NEO MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NeoMagic
- Primary DI
- B339307616080
- Version / Model
- 3076-1608
- Catalog Number
- 3076-1608
- Company Name
- NEO MEDICAL INC.
- Labeler DUNS
- 015510540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-08-02
- Public Version Status
- Update
- Public Device Record Key
- da58b45e-8c5c-4c33-bc8f-716184cf0508
Device Description
3.0Fr (20ga) x 8cm Single Lumen EPIV with Stylet and Introducer
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64573 | Peripheral intravenous catheterization kit | A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B339307616085 | HIBCC | Case | 10 | In Commercial Distribution | |
| Primary | B339307616080 | HIBCC |
Customer Contacts
- Phone
- 888-450-3334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983916 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.0 | Centimeter | |
| Catheter Gauge | 3.0 | French |