FDA UDI
In Commercial Distribution
🇺🇸 United States
eZSURE™
DI: 18859299123636
·
Model: 426110SF
·
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- eZSURE™
- Primary DI
- 18859299123636
- Version / Model
- 426110SF
- Company Name
- EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- Labeler DUNS
- 662213220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-04-10
- Public Version
- 2
- Public Version Date
- 2026-04-23
- Public Version Status
- Update
- Public Device Record Key
- 25f67472-e20e-4eec-abdf-377347725488
Device Description
Empty Fluid Container 500 ml Max Capacity (NFV Fill Port with Seal-Tab) (Non-Capped)
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
- 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 |
|---|---|---|---|---|
| KPE | Container, I.V. | General Hospital | 880.5025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35127 | Intravenous administration bag/bottle | An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38859299123630 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 18859299123636 | GS1 | ||||
| Unit of Use | 78859299123638 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223674 | 000 |