AccessGUDID - DEVICE: Shape-HF (B20044001)

GUDID

Device Identifier (DI) Information

Brand Name: Shape-HF
Version or Model: Disposable Patient Interface
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shape Medical Systems, Inc.

Primary DI Number: B20044001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021315587 *Terms of Use

Device Description: Disposable Patient Interface is part of the Shape-HF testing system

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):	No
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?
60506	Pulmonary function testing kit	A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTY	Calculator, Predicted Values, Pulmonary Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090722	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
No Device Sizes

Device Record Status

Public Device Record Key: f8b0507e-13e7-420e-9a79-6b80b90f962d
Public Version Date: March 07, 2022
Public Version Number: 4
DI Record Publish Date: September 13, 2016