FDA UDI
In Commercial Distribution
🇺🇸 United States
eZSURE™
DI: 18859299136179
·
Model: 426170
·
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- eZSURE™
- Primary DI
- 18859299136179
- Version / Model
- 426170
- Company Name
- EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- Labeler DUNS
- 662213220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-07-31
- Public Version
- 2
- Public Version Date
- 2025-09-29
- Public Version Status
- Update
- Public Device Record Key
- f8420940-f0dc-40f5-937c-772beaf31a60
Device Description
Tamper Evident Cap
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 |
|---|---|---|---|---|
| 65151 | Non-ISO80369-standardized fluid path protective cover | A small, noninvasive, closed-ended attachment not designed according to ISO 80369 (non-ISO80369-standardized) intended to cover and close off (cap/plug) a luminal device associated with management of fluids (e.g., urological catheter, administration set, bag access spike). It is designed with a connection that is typically barbed, bayonet, collet, conical, threaded and/or non-Luer-slip; it is not intended to be used with respiratory or surgical equipment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38859299136173 | GS1 | Carton | 100 | In Commercial Distribution | |
| Primary | 18859299136179 | GS1 | ||||
| Unit of Use | 28859299136176 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223674 | 000 |