NA

Primary DI
10810021174034
Brand
NA
Company
Dongguan SIMZO Electronic Technology Co., Ltd.
Model
NBM-6B
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230379000Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd.2023-11-27CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810021174034PackageGS148In Commercial Distribution
00810021174037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002117403410810021174034
00810021174037008100211740378100211740370810021174037

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory nebulizer, non-heatedAn electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544332470
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198715785128AirpulseNBM-6B2026-01-02
00810021174006NANBM-3B2025-11-19
00810021174037NANBM-6B2024-01-03
00810021174396BalnoreNBM-4B2025-09-16
00810021174341CadeVitaNBM-8B2025-07-14
00810021174372SRBCareNBM-9B2025-07-14
00810021174389SRBCareNBM-9B2025-07-14
00810021174334AlphamedNBM-7B2025-07-10
00810021174235RALIMINBM-112025-02-15
00810021174259AirpulseNBM-6B2025-02-15
00810021174266AnthsaniaNBM-12025-02-15
00810021174273HARTONNBM-6B2025-02-15
00810021174013NANBM-7B2024-01-03
00810021178394BLUE JAYHW-F32025-05-30
00810021171173SIMZOHW-12020-03-30
00810021171180SIMZOHW-E012020-05-29
00810021171166SIMZOHW-B052020-06-04
00810021171197simzoHW-F72020-06-04
00810021171203SIMZOHW-F72019-08-17
00810021171210SIMZOHW-F72019-08-17

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10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
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10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
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