AccessGUDID - DEVICE: The Vest APX System (00887761967243)

GUDID

Device Identifier (DI) Information

Brand Name: The Vest APX System
Version or Model: M08463
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HILL-ROM SERVICES PTE. LTD.

Primary DI Number: 00887761967243
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595156263 *Terms of Use

Device Description: The Vest APX Control Unit (High Frequency Chest Wall Oscillation Device)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
38124	Chest-oscillation airway secretion-clearing system	An assembly of devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) oscillating pressurized air generator, an inflatable vest (jacket) to be worn by the patient and a connecting hose. It is intended to be operated by a healthcare professional in a professional setting.	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
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1bfcb0f-c893-4860-ad2d-f132893a8da5
Public Version Date: September 16, 2024
Public Version Number: 1
DI Record Publish Date: September 06, 2024

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)445-3730
Email: us.customerservice@hill-rom.com

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