Primary Device ID | 16944932754321 |
NIH Device Record Key | 09e4560f-4d6b-4683-8a1b-aa2061c58e14 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | All Silicone Foley Catheter |
Version Model Number | F01B031205 |
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 | 06944932754324 [Primary] |
GS1 | 16944932754321 [Package] Contains: 06944932754324 Package: Box [10 Units] In Commercial Distribution |
GS1 | 26944932754328 [Package] Package: Carton [50 Units] In Commercial Distribution |
EZL | Catheter, Retention Type, Balloon |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-27 |
Device Publish Date | 2024-05-17 |
16944932755458 | 3-way Standard 26Fr30ml |
16944932755441 | 3-way Standard 26Fr15ml |
16944932755434 | 3-way Standard 26Fr10ml |
16944932755427 | 3-way Standard 26Fr5-15ml |
16944932755410 | 3-way Standard 26Fr5-10ml |
16944932755397 | 3-way Standard 24Fr30ml |
16944932755380 | 3-way Standard 24Fr15ml |
16944932755373 | 3-way Standard 24Fr10ml |
16944932755366 | 3-way Standard 24Fr5-15ml |
16944932755342 | 3-way Standard 24Fr5-10ml |
16944932755328 | 3-way Standard 22Fr30ml |
16944932755311 | 3-way Standard 22Fr15ml |
16944932755304 | 3-way Standard 22Fr10ml |
16944932755298 | 3-way Standard 22Fr5-15ml |
16944932755281 | 3-way Standard 22Fr5-10ml |
16944932755267 | 3-way Standard 20Fr30ml |
16944932755250 | 3-way Standard 20Fr15ml |
16944932755243 | 3-way Standard 20Fr10ml |
16944932755236 | 3-way Standard 20Fr5-15ml |
16944932755229 | 3-way Standard 20Fr5-10ml |
16944932755205 | 3-way Standard 18Fr30ml |
16944932755199 | 3-way Standard 18Fr15ml |
16944932755182 | 3-way Standard 18Fr10ml |
16944932755175 | 3-way Standard 18Fr5-15ml |
16944932755168 | 3-way Standard 18Fr5-10ml |
16944932755144 | 3-way Standard 16Fr30ml |
16944932755137 | 3-way Standard 16Fr15ml |
16944932755120 | 3-way Standard 16Fr10ml |
16944932755113 | 3-way Standard 16Fr5-15ml |
16944932755106 | 3-way Standard 16Fr5-10ml |
16944932754383 | 2-way Female 14Fr10ml |
16944932754376 | 2-way Female 14Fr5-15ml |
16944932754369 | 2-way Female 14Fr5-10ml |
16944932754345 | 2-way Female 12Fr10ml |
16944932754338 | 2-way Female 12Fr5-15ml |
16944932754321 | 2-way Female 12Fr5-10ml |
16944932754000 | 2-way Standard 26Fr30ml |
16944932753997 | 2-way Standard 26Fr10ml |
16944932753980 | 2-way Standard 26Fr5-15ml |
16944932753973 | 2-way Standard 26Fr5-10ml |
16944932753966 | 2-way Standard 26Fr5ml |
16944932753942 | 2-way Standard 24Fr30ml |
16944932753928 | 2-way Standard 24Fr15ml |
16944932753911 | 2-way Standard 24Fr10ml |
16944932753904 | 2-way Standard 24Fr5-15ml |
16944932753898 | 2-way Standard 24Fr5-10ml |
16944932753881 | 2-way Standard 24Fr5ml |
16944932753867 | 2-way Standard 22Fr30ml |
16944932753843 | 2-way Standard 22Fr15ml |
16944932753836 | 2-way Standard 22Fr10ml |