AccessGUDID - DEVICE: AffloVest (00816305023725)

GUDID

Device Identifier (DI) Information

Brand Name: AffloVest
Version or Model: 8046
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Tactile Systems Technology, Inc.

Primary DI Number: 00816305023725
Issuing Agency: GS1
Commercial Distribution End Date: March 25, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 146295980 *Terms of Use

Device Description: AffloVest 12V Car Power Inverter

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:	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?
45292	Chest-percussion airway secretion-clearing system	An assembly of devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient (child to adult) 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) applicator with connecting cable and a control unit. The device is portable and operated by a healthcare professional in a medical facility or in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYI	Percussor, Powered-Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122480	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: 7dbe81ba-6dc9-4c3b-bf00-a1d0ac05f3e6
Public Version Date: April 22, 2025
Public Version Number: 3
DI Record Publish Date: May 08, 2022

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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