Device
Pressure Infusion Bag, Clear Back, 1000ml, Reusable
Manufacturer
Transparent Supply Solutions Ltd.
Model: 8821 DI: 00199536933767 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
Pressure Infusion Bag, Clear Back, 1000ml, Reusable
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5c01fa6a-f227-4009-b926-180e8fc0743e
Distribution Status: In Commercial Distribution
DUNS Number: 119522714
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: CASE
Item #1 - Device ID: 50199536933762
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 20
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00199536933767
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00199536933767
Item #2 - Device ID Type: Primary
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