AccessGUDID - DEVICE: STATCORP MEDICAL (10841522124334)

GUDID

Device Identifier (DI) Information

Brand Name: STATCORP MEDICAL
Version or Model: STATCORP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2903TGA-24
Company Name: Statcorp Medical

Primary DI Number: 10841522124334
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 602075905 *Terms of Use

Device Description: UNIFUSOR II,500ML,PISTON,THUMBWHEEL,24/BX

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13100	Intravenous pressure infusor, manual, reusable	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZD	INFUSOR, PRESSURE, FOR I.V. BAGS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29f7217b-51f8-41c4-983c-622927ec9f6b
Public Version Date: June 30, 2021
Public Version Number: 7
DI Record Publish Date: January 31, 2018