AccessGUDID - DEVICE: DISPIRO (H671024601)

GUDID

Device Identifier (DI) Information

Brand Name: DISPIRO
Version or Model: 10 Liter with 22mm Connector
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02460
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671024601
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: BULK PACK, 10 LITER COLLECTION BAG W/ 22MM CONNECTOR

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?
11850	Gasometer	A calibrated container that is usually balanced over water and intended to measure lung gas volumes. Also known as a wet spirometer. This GMDN code reflects old technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZG	Spirometer, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K791177	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 22 Millimeter
Total Volume: 10 Liter

Device Record Status

Public Device Record Key: c6e4b799-7b0e-4cc8-9ace-fd015d767a2f
Public Version Date: December 18, 2019
Public Version Number: 4
DI Record Publish Date: September 22, 2016