FDA UDI In Commercial Distribution 🇺🇸 United States

PowerFlow Apheresis IV Port Intermediate Kit

DI: 00801741129438 · Model: A710962 · Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
PowerFlow Apheresis IV Port Intermediate Kit
Primary DI
00801741129438
Version / Model
A710962
Catalog Number
A710962
Company Name
Bard Access Systems, Inc.
Labeler DUNS
044611812
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-05-18
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
1bf431be-39ab-4fc1-9010-778a17e30f7d

Device Description

PowerFlow 9.6Fr ChronoFlex Implantable Apheresis IV Port Intermediate Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
PTD Subcutaneous implanted apheresis port

GMDN Terms

Code Name
58091 Apheresis kit

Identifiers

Type ID
Package 10801741129435
Primary 00801741129438

Customer Contacts

Device Sizes

Type Value Unit Text
Catheter Gauge 9.6 French
Length 45 Centimeter