AccessGUDID - DEVICE: DISPIRO (H671020001)

GUDID

Device Identifier (DI) Information

Brand Name: DISPIRO
Version or Model: 10 Liter Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02000
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671020001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: 10 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02400

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:	Yes
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
Total Volume: 10 Liter

Device Record Status

Public Device Record Key: d56343a4-4211-4471-87ab-d794b0dc1a98
Public Version Date: December 17, 2019
Public Version Number: 4
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: H671020000 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-533-4984
Email: customer@utahmed.com

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