Device
Pressure Infuser Bag, with Bulb, 500ML, Non-Sterile, Latex Free
Manufacturer
Concordance Healthcare Solutions LLC
Concordance Healthcare Solutions LLC
Model: 9201-500
DI: 00810132043789
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
Pressure Infuser Bag, with Bulb, 500ML, Non-Sterile, Latex Free
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f979830e-22ff-43a6-ba68-755a39a79ffc
Distribution Status:
In Commercial Distribution
DUNS Number:
080220245
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
00810132043789
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10810132043786
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
30
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00810132043789
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 13100
Name: Intravenous pressure infusor, manual, reusable
Definition:
A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.
FDA Product Codes
KZD
Infusor, Pressure, For I.V. Bags