FDA UDI
In Commercial Distribution
🇺🇸 United States
ProSeal CSTD
DI: 18859299119950
·
Model: 423370ST
·
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
- 18859299119950
- Version / Model
- 423370ST
- 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
- 8b7b32fc-2a09-4a6f-a408-2f013eac5ecb
Device Description
ProSeal Spike with Additive Port and Seal Tab (DMA Compatible)
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 |
|---|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64997 | Non-ISO80369 formatted bag access spike | A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38859299119954 | GS1 | Carton | 200 | In Commercial Distribution | |
| Primary | 18859299119950 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251340 | 000 |