FDA UDI
In Commercial Distribution
🇺🇸 United States
PORT ACCESS INFUSION SET
DI: 00646311550812
·
Model: PI01Y03
·
SB-KAWASUMI LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PORT ACCESS INFUSION SET
- Primary DI
- 00646311550812
- Version / Model
- PI01Y03
- Catalog Number
- PI01Y03
- Company Name
- SB-KAWASUMI LABORATORIES, INC.
- Labeler DUNS
- 690625850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 8
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 3c9d9776-c865-4285-85a6-f4f91c5bec9d
Device Description
Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in hospitals, and for chemotherapy.
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 |
|---|---|---|---|---|
| FRN | Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17701 | Vascular port administration set | A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00646311550812 | GS1 |
Customer Contacts
- Phone
- (813)630-5554
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 20 | Gauge |