AccessGUDID - DEVICE: Sphere™ Inflation Device (00827002496743)

GUDID

Device Identifier (DI) Information

Brand Name: Sphere™ Inflation Device
Version or Model: QL4015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CID-40-15
Company Name: ATRION MEDICAL PRODUCTS, INC.

Primary DI Number: 00827002496743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047571476 *Terms of Use

Device Description: Inflation Device Atrion Part Number 96364A: 40mL, 15atm

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":	No
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?
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOE	Dilator, Urethral
MAV	Syringe, Balloon Inflation

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5319cb2a-69e6-4957-a96e-b2ed61f131cc
Public Version Date: January 08, 2021
Public Version Number: 6
DI Record Publish Date: September 21, 2016