Shape-HF

Basic Information

• Brand Name: Shape-HF
• Primary DI: B20044001
• Version / Model: Disposable Patient Interface
• Company Name: Shape Medical Systems, Inc.
• Labeler DUNS: 021315587
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 4
• Public Version Date: 2022-03-07
• Public Version Status: Update
• Public Device Record Key: f8b0507e-13e7-420e-9a79-6b80b90f962d

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B20044001	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K090722	000