Model: H6HC
DI: 06971331400453
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Nebulizer Accessory Set
Sterilization
Method Types - Sterilization Method:
High-level Disinfectant
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
271e466f-4a64-4738-9b19-0b1d1a03d640
Distribution Status:
In Commercial Distribution
DUNS Number:
544320977
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06971331400453
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35457
Name: Therapeutic agent nebulizer, benchtop
Definition:
An assembly of devices intended to be used in the home and clinical 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., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.
FDA Product Codes
CAF
Nebulizer (Direct Patient Interface)
Premarket Submissions
Submission Number:
K251659
Supplement Number:
000