FDA.reportPublic FDA data

Clever Choice

Primary DI
00850002860498
Brand
Clever Choice
Company
S.D.I. USA, INC.
Model
Universal Fit Reusable Nebulizer Kit - CHILD
Device description
Clever Choice Universal Fit Reusable Nebulizer Kit - Child 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
10850002860495PackageGS175In Commercial Distribution
00850002860498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000286049510850002860495
00850002860498008500028604988500028604980850002860498

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.

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
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
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