FDA UDI
In Commercial Distribution
🇺🇸 United States
ProSeal CSTD
DI: 18859299133505
·
Model: 423500
·
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ProSeal CSTD
- Primary DI
- 18859299133505
- Version / Model
- 423500
- Company Name
- EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED
- Labeler DUNS
- 662213220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-11
- Public Version
- 2
- Public Version Date
- 2025-09-29
- Public Version Status
- Update
- Public Device Record Key
- f198c87c-184a-4f29-994a-b7e1d4117316
Device Description
ProSeal Closed System Administration Set
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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38859299133509 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 18859299133505 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230343 | 000 |