| Primary Device ID | 16936881199933 |
| NIH Device Record Key | 635e153b-4561-49cb-9afb-012740608c46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Latex Foley Catheter |
| Version Model Number | F01A101804 |
| Company DUNS | 544811862 |
| Company Name | Well Lead Medical Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06936881199936 [Primary] |
| GS1 | 16936881199933 [Package] Contains: 06936881199936 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 26936881199930 [Package] Package: Carton [50 Units] In Commercial Distribution |
| MJC | Catheter, Urological (Antimicrobial) And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-05-31 |
| 16944932764061 | 3 way standard 26Fr30-50ml |
| 16944932764054 | 3 way standard 26Fr5-15ml |
| 16944932764030 | 3 way standard 24Fr30-50ml |
| 16944932764016 | 3 way standard 24Fr5-15ml |
| 16944932764009 | 3 way standard 24Fr5-10ml |
| 16944932763972 | 3 way standard 22Fr30-50ml |
| 16944932763958 | 3 way standard 22Fr5-15ml |
| 16944932763941 | 3 way standard 22Fr5-10ml |
| 16944932763910 | 3 way standard 20Fr30-50ml |
| 16944932763897 | 3 way standard 20Fr5-15ml |
| 16944932763880 | 3 way standard 20Fr5-10ml |
| 16944932763859 | 3 way standard 18Fr30-50ml |
| 16944932763835 | 3 way standard 18Fr5-15ml |
| 16944932763828 | 3 way standard 18Fr5-10ml |
| 16944932763804 | 3 way standard 16Fr30-50ml |
| 16944932763781 | 3 way standard 16Fr5-15ml |
| 16944932762371 | 2 way Female 26Fr5-15ml |
| 16944932762364 | 2 way Female 24Fr30ml |
| 16944932762340 | 2 way Female 24Fr5-15ml |
| 16944932762333 | 2 way Female 22Fr30ml |
| 16944932762302 | 2 way Female 22Fr5-15ml |
| 16944932762296 | 2 way Female 22Fr5-10ml |
| 16944932762289 | 2 way Female 22Fr5ml |
| 16944932762272 | 2 way Female 20Fr30ml |
| 16944932762258 | 2 way Female 20Fr10ml |
| 16944932762234 | 2 way Female 20Fr5-15ml |
| 16944932762227 | 2 way Female 20Fr5-10ml |
| 16944932762210 | 2 way Female 20Fr5ml |
| 16944932762203 | 2 way Female 18Fr30ml |
| 16944932762180 | 2 way Female 18Fr10ml |
| 16944932762166 | 2 way Female 18Fr5-15ml |
| 16944932762159 | 2 way Female 18Fr5-10ml |
| 16944932762142 | 2 way Female 18Fr5ml |
| 16944932762135 | 2 way Female 16Fr30ml |
| 16944932762111 | 2 way Female 16Fr15ml |
| 16944932762104 | 2 way Female 16Fr10ml |
| 16944932762081 | 2 way Female 16Fr5-10ml |
| 16944932762074 | 2 way Female 16Fr5ml |
| 16944932762067 | 2 way Female 14Fr30ml |
| 16944932762050 | 2 way Female 14Fr15-30ml |
| 16944932762043 | 2 way Female 14Fr15ml |
| 16944932762036 | 2 way Female 14Fr10ml |
| 16944932762012 | 2 way Female 14Fr5-15ml |
| 16944932762005 | 2 way Female 14Fr5-10ml |
| 16944932761992 | 2 way Female 14Fr5ml |
| 16944932761985 | 2 way Female 12Fr30ml |
| 16944932761978 | 2 way Female 12Fr15ml |
| 16944932761961 | 2 way Female 12Fr10ml |
| 16944932761947 | 2 way Female 12Fr5-15ml |
| 16944932761930 | 2 way Female 12Fr5-10ml |