GEN4 Plus, Direct Access

142 catalogue numbers from 5C19FN-Z10300008, listed by Curbell Medical Products, Inc., United States, under System, Environmental Control, Powered. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
142catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code IQA
Manufacturer City Province Registered as Device types
Yuiyn HOO Industrial Limited Dong Guan Guangdong Contract manufacturer 3

Record

Regulatory record for GEN4 Plus, Direct Access
Listed by Curbell Medical Products, Inc., United States
FDA product code IQA
Device type System, Environmental Control, Powered
Device class Class 2
Regulation 21 CFR 890.3725
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2019-04-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for GEN4 Plus, Direct Access
Catalogue number Size Status
5C19FN-Z10300008 In distribution
5C331U-Z00500038 In distribution
5C19EU-Z10300028 In distribution
5C19DU-Z10400028 In distribution
5C331U-Z05600538 In distribution
5C330U-Z10300011 In distribution
5C383U-Z10300008 In distribution
5C190U-Z11500488 In distribution
5C331U-Z16000588 In distribution
5C19DU-Z11900128 In distribution
5C380U-Z10500011 In distribution
5C331U-Z05800528 In distribution
5C331U-Z1000000A In distribution
5C190U-Z10400038 In distribution
5C190U-ZD0300028 In distribution
5C422U-Z12700028 In distribution
5C331U-Z5000100C In distribution
5C19CU-P10400008 In distribution
5C331U-Z16909838 In distribution
5C19FN-P10300008 In distribution
5C190U-Z1080040C In distribution
5C331U-Z10300008 In distribution
5C331U-Z0050403C In distribution
5C331U-Z10300001 In distribution
5C193U-Z00300018 In distribution
5C19AN-Z10300008 In distribution
5C331U-Z1030001C In distribution
5C430U-Z3020000F In distribution
5C19EU-Z10000038 In distribution
5C19CU-Z10300048 In distribution
5C19CU-Z10300068 In distribution
5C421U-Z1030600F In distribution
5C19CU-Z10000008 In distribution
5C050U-P10000288 In distribution
5C19CU-Z00000088 In distribution
5C331U-Z00900028 In distribution
5C331U-Z01900078 In distribution
5C19DU-P10000028 In distribution
5C190U-Z1040002F In distribution
5C421U-Z1030000C In distribution
5C19CU-Z10300058 In distribution
5C19CU-P10400028 In distribution
5C190U-Z11800448 In distribution
5C19DU-Z10000028 In distribution
5C19AN-Z10000018 In distribution
5C190U-Z16000248 In distribution
5C190U-Z11600378 In distribution
5C240U-Z1000000C In distribution
5C19TU-Z13100008 In distribution
5C383U-Z10700008 In distribution
5C19CU-Z10000038 In distribution
5C19EU-P10400038 In distribution
5C331U-Z10000001 In distribution
5C331U-Z10000018 In distribution
5C19DU-Z10000038 In distribution
5C331U-Z10000008 In distribution
5C331U-Z15600838 In distribution
5C331U-Z1640001C In distribution
5C19CU-Z10400008 In distribution
5C331U-Z06500538 In distribution
5C19TU-Z10900008 In distribution
5C331U-Z1550051C In distribution
5C19FN-Z1030000C In distribution
5C19DU-Z00300068 In distribution
5C331U-Z16300018 In distribution
5C331U-Z16200018 In distribution
5C19AN-Z0030002C In distribution
5C190U-Z12300028 In distribution
5C19CU-Z16900048 In distribution
5C331U-Z10400018 In distribution
5C19DN-Z1040020C In distribution
5C331U-Z01900028 In distribution
5C331U-Z1050001H In distribution
5C331U-Z16800048 In distribution
5C19AN-Z00300028 In distribution
5C331U-Z0050503C In distribution
5C19CU-P10300048 In distribution
5C331U-Z10300258 In distribution
5C19AN-Z10300018 In distribution
5C19FN-Z00300028 In distribution
5C331U-Z16400008 In distribution
5C19EU-P00000008 In distribution
5C331U-Z15900588 In distribution
5C19CU-P10000028 In distribution
5C331U-Z01900038 In distribution
5C331U-Z00500028 In distribution
5C380U-Z10500001 In distribution
5C190U-Z90000028 In distribution
5C331U-P11900018 In distribution
5C19EU-Z10400028 In distribution
5C331U-Z16400018 In distribution
5C19DU-Z10400038 In distribution
5C19EU-P10000028 In distribution
5C430U-Z30200001 In distribution
5C19AN-Z00000038 In distribution
5C19EU-Z10000028 In distribution
5C430U-Z30000029 In distribution
5C331U-Z16900018 In distribution
5C19AN-Z00000028 In distribution
5C331U-P16300018 In distribution
5C331U-Z10300798 In distribution
5C19CU-Z10400038 In distribution
5C331U-Z0050003C In distribution
5C190U-Z11700368 In distribution
5C19EU-P10400028 In distribution
5C19DU-Z15900178 In distribution
5C190U-P1030702F In distribution
5C19CU-Z10000018 In distribution
5C190U-Z15300368 In distribution
5C19BU-Z10400008 In distribution
5C331U-Z0050403H In distribution
5C19CU-Z10000028 In distribution
5C19DU-Z17200168 In distribution
5C331U-R10300018 In distribution
5C19DU-Z10300048 In distribution
5C331U-Z05600858 In distribution
5C19DU-Z15900058 In distribution
5C19BU-P10000028 In distribution
5C19CU-P10000018 In distribution
5C19DU-P10400028 In distribution
5C331U-P10500008 In distribution
5C331U-Z10300018 In distribution
5C19UN-Z10400008 In distribution
5C19JU-Z10300071 In distribution
5C19BU-Z10000008 In distribution
5C19UN-Z10400018 In distribution
5C330U-Z51708808 In distribution
5C19AN-Z10000008 In distribution
5C331U-R16700018 In distribution
5C19DN-Z1100016C In distribution
5C19EU-Z00000018 In distribution
5C190U-Z10800408 In distribution
5C331U-P10900008 In distribution
6C242U-Z103008 In distribution
5C19TU-Z03100038 In distribution
5C331U-P1450070A In distribution
5C19FN-Z10400018 In distribution
5C331U-Z16500508 In distribution
5C19FN-Z10000008 In distribution
5C190U-Z11600368 In distribution
5C380U-Z10500001 In distribution
5C420U-Z1000000A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEN4 Digital Curbell Medical Products, Inc. 922
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Elite Digital Crest Healthcare Supply 71
Amplion Care Assurance Amplion Clinical Communications, Inc. 67
Elite Infrared Crest Healthcare Supply 59
Responder 5, Standard Curbell Medical Products, Inc. 33
Excel Digital Crest Healthcare Supply 28
Responder 5, Standard,no Entertainment Curbell Medical Products, Inc. 28
Excel EntertainIR Crest Healthcare Supply 24
GEN4 Direct Access Curbell Medical Products, Inc. 23

Showing 12 of 819. All products under System, Environmental Control, Powered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer