AccessGUDID - DEVICE: Hobbs Medical Mistifier Spray Catheter (M84921900)

GUDID

Device Identifier (DI) Information

Brand Name: Hobbs Medical Mistifier Spray Catheter
Version or Model: 2190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2190
Company Name: HOBBS MEDICAL, INC.

Primary DI Number: M84921900
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076769355 *Terms of Use

Device Description: A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.

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?
61511	Endoscopic spray catheter, single-use	A flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal colouration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCX	Endoscopic Irrigation/Suction System
EOQ	Bronchoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030765	000

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: addd7674-19bf-4343-9020-f6b87a675cc2
Public Version Date: April 07, 2021
Public Version Number: 4
DI Record Publish Date: September 21, 2016