FDA.reportPublic FDA data

Clinical Guard

Primary DI
24719872486026
Brand
Clinical Guard
Company
HEALTH & LIFE CO., LTD.
Model
HL100
Device description
Nebulizer
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
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
K081738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081738000ULTRASONIC NEBULIZER SYSTEM, MODEL HL100Health & Life Co., Ltd.2008-09-17CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719872486029PackageGS120In Commercial Distribution
24719872486026PackageGS1150In Commercial Distribution
04719872486022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987248602914719872486029
2471987248602624719872486026
04719872486022047198724860224719872486022

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic nebulizing systemAn assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657836743
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
04719872489238Hello HeartHHBPA-CUFFXL2025-12-04
04719872483571HomedicsBPA-945B2025-06-10
04719872483496Hello HeartHHBPA-100BT2025-04-18
04719872483502Homedics1565256A-6SH/ BPA-960BTA-WT2025-03-27
04719872480013WalgreensWGNBPW-9102016-06-13
04719872480020WalgreensWGNBPW-9202016-06-13
04719872480167WRISTECH82-36492016-08-11
04719872480181WRISTECH ZB-3649 2016-08-17
04719872480204HoMedicsBPW-O2002018-06-22
04719872483014WalgreensWGNBPA-9402016-06-13
04719872483021WalgreensWGNBPA-9502016-06-13
04719872483038WalgreensWGNBPA-960BT2016-06-13
04719872483205WalgreensWGNBPA-9452017-10-30
04719872483229HoMedicsBPA-O2002018-06-22
04719872483236HoMedicsBPA-0652019-04-01
04719872483243PRESTIGEHM-30-OB2019-02-27
04719872483250 PRESTIGEHM-352019-02-27
04719872483267Prime AlertPA0012019-02-27
04719872483274HM01WMTBPA-240BT2021-08-02
04719872486022Clinical GuardHL1002016-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
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10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
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10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02