FDA UDI Not in Commercial Distribution 🇺🇸 United States

PORT ACCESS INFUSION SET

DI: 00646311550591 · Model: PI05020 · 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
00646311550591
Version / Model
PI05020
Company Name
SB-KAWASUMI LABORATORIES, INC.
Labeler DUNS
690625850
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
6
Public Version Date
2024-01-29
Public Version Status
Update
Public Device Record Key
dc170bc8-7dd7-422e-a1f0-ba663fe5ce9c
Distribution End Date
2023-12-31

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
FRN Pump, Infusion

GMDN Terms

Code Name
17701 Vascular port administration set

Identifiers

Type ID
Primary 00646311550591