FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoMagic
DI: B33925251620
·
Model: 2525-162
·
Neo Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NeoMagic
- Primary DI
- B33925251620
- Version / Model
- 2525-162
- Catalog Number
- 2525-162
- Company Name
- Neo Medical Inc.
- Labeler DUNS
- 015510540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-22
- Public Version
- 3
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- 88fbacd8-75dd-4d35-a371-cd90f17bcc1d
Device Description
2.5Fr x 20cm Single Lumen Polyurethane Midline Catheter with MST Introducer Kit.
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, non-sensing | A collection of non-powered 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 |
|---|---|---|---|---|---|---|
| Primary | B33925251620 | HIBCC | ||||
| Package | B33925251625 | HIBCC | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 888-450-3334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983916 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 2.5 | French | |
| Length | 20 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away From Sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry