AccessGUDID - DEVICE: SmartVest (B102060078S0240)

GUDID

Device Identifier (DI) Information

Brand Name: SmartVest
Version or Model: SV-28-CM-BU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SV-28-CM-BU
Company Name: ELECTROMED, INC.

Primary DI Number: B102060078S0240
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036514250 *Terms of Use

Device Description: LTU SmartVest® – Child Medium (Blue)

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:	No
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?
38122	Chest-oscillation airway secretion-clearing system vest	A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYI	Percussor, Powered-Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: a4ec2c6c-2cdf-486a-bc49-fd165ffc0bd7
Public Version Date: December 11, 2019
Public Version Number: 3
DI Record Publish Date: September 16, 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: No Unit of Use DI Numbers Found 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

[?]

No Customer Contact currently defined

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