FDA UDI In Commercial Distribution 🇺🇸 United States

BIOSITE/BIOSITE PLUS

DI: B134JR009HU2 · Model: JR-009-HU · MACLIN POWER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

Basic Information

Brand Name
BIOSITE/BIOSITE PLUS
Primary DI
B134JR009HU2
Version / Model
JR-009-HU
Catalog Number
JR-009-HU
Company Name
MACLIN POWER, INC.
Labeler DUNS
962650714
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2016-12-30
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
8b7a5fd6-a79c-4c52-9cbe-1caa5f58b573

Device Description

JR-009-HU 300 PSI High-Pressure Needleless Neutral Valve

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
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
12170 Intravenous administration tubing extension set

Identifiers

Type ID
Primary B134JR009HU2
Unit of Use B134JR009HU0