Primary Device ID | 30887709097101 |
NIH Device Record Key | e4046ddd-a75c-426d-a071-c5e5d3be31a0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SwabSleeve™ |
Version Model Number | SCXT3-5-2000 |
Catalog Number | SCXT3-5-2000 |
Company DUNS | 118380146 |
Company Name | ICU MEDICAL, INC. |
Device Count | 5 |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com | |
Phone | +1(866)829-9025 |
customerservice@icumed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00887709097100 [Unit of Use] |
GS1 | 10887709097107 [Primary] |
GS1 | 20887709097104 [Package] Contains: 10887709097107 Package: [50 Units] In Commercial Distribution |
GS1 | 30887709097101 [Package] Contains: 20887709097104 Package: [8 Units] In Commercial Distribution |
QBP | Cap, device disinfectant |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-15 |
Device Publish Date | 2024-04-05 |
10887709161785 - Bivona | 2025-07-04 FU25FN40NSA180N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709161808 - Bivona | 2025-07-04 FU25FN40NGA196N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709161815 - Bivona | 2025-07-04 FT25FN40NGF197N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709161884 - Bivona | 2025-07-04 SU25FN35NSC204N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile |
10887709161891 - Bivona | 2025-07-04 FU25FN60NGF202N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709161907 - Bivona | 2025-07-04 FU25FN45NSA206N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709161914 - Bivona | 2025-07-04 FU25FN60NGF203N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
10887709162065 - Bivona | 2025-07-04 HA25FS75NSC231N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SWABSLEEVE 87691987 not registered Live/Pending |
ICU Medical, Inc. 2017-11-20 |