FDA.reportPublic FDA data

Clever Choice

Primary DI
00850002860481
Brand
Clever Choice
Company
S.D.I. USA, INC.
Model
Universal Fit Reusable Nebulizer Kit
Device description
Clever Choice Universal Fit Reusable Nebulizer KitAdult SizeContains Nebulizer Mask with elastic strap, Nebulizer Cup, 5 x Filters, Mouth Piece, and Air Tube with Connectors.
Published
2022-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850002860488PackageGS175In Commercial Distribution
00850002860481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000286048810850002860488
00850002860481008500028604818500028604810850002860481

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, reusableA collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.877.342.2385customerservice@simplediagnostics.com

Regulatory Flags#

DUNS number
116722847
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083784003Comfort EZLL12026-02-13
00850083784041Comfort EZLL1INS2026-02-13
00850083784058Comfort EZHYP18G12026-02-13
00850083784171Comfort EZHYP25G1S2026-02-13
00850083784270Comfort EZSS23G3ML12026-02-13
00850083784324Comfort EZSSTB25G1ML582026-02-13
00850083784348Comfort EZNS18G3ML1.52026-02-13
00850083784409Comfort EZBLN18G1.52026-02-13
20850083784007Comfort EZLL12026-02-13
20850083784045Comfort EZLL1INS2026-02-13
20850083784052Comfort EZHYP18G12026-02-13
20850083784175Comfort EZHYP25G1S2026-02-13
20850083784274Comfort EZSS23G3ML12026-02-13
20850083784328Comfort EZSSTB25G1ML582026-02-13
20850083784342Comfort EZNS18G3ML1.52026-02-13
20850083784403Comfort EZBLN18G1.52026-02-13
00850002860702Comfort EZ ProSPN-30G850002-0860-702023-08-01
00850002860719Comfort EZ ProSPN-31G550002-0860-712023-08-01
00850002860726Comfort EZ ProSPN-31G450002-0860-722023-08-01
10850002860709Comfort EZ ProSPN-30G850002-0860-702023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
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
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02