Device
Compressor Nebullizer Pediatric (Chill the Penguin) Spare Filters
Manufacturer
VIVE HEALTH LLC
VIVE HEALTH LLC
Model: LVA3085FLT
DI: 00810178881758
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-26
Current Version: 2026-05-04
Description
Compressor Nebullizer Pediatric (Chill the Penguin) Spare Filters
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7367b025-d535-4079-85ca-a098f1ec90f6
Distribution Status:
In Commercial Distribution
DUNS Number:
047025993
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810178881758
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66295
Name: Therapeutic agent nebulizer, ambulatory
Definition:
An electrically-powered, hand-held, portable device intended to be used outside of a clinical setting (e.g., home, outdoors) to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.
FDA Product Codes
CAF
Nebulizer (Direct Patient Interface)