| Primary Device ID | 00197998465239 |
| NIH Device Record Key | e07183a1-c03a-48ac-9da1-54d3c173def6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solventum US LLC |
| Version Model Number | EX-1123833 |
| Catalog Number | EX-1123833 |
| Company DUNS | 119004140 |
| Company Name | Solventum US LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com | |
| Phone | +1(800)228-3957 |
| regulatoryrequests@solventum.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00197998465239 [Primary] |
| KCQ | TUBE IMPRESSION AND MATRIX |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |
| 00197998470486 - Littmann® Classic III™ | 2026-02-11 Littmann® Classic III™ Stethoscope, 5620C, Stainless-finishChestpiece, Satin-finish Black Tube |
| 00197998470509 - Littmann® Classic III™ | 2026-02-11 Littmann® Classic III™ Stethoscope, 5648C, Stainless-finishChestpiece, Satin-finish Raspberry Tube |
| 00197998470523 - Littmann® Classic III™ | 2026-02-11 Littmann® Classic III™ Stethoscope, 5623C, Stainless-finishChestpiece, Satin-finish Caribbean Blue Tube |
| 00197998470547 - Littmann® Cardiology IV™ | 2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6177C, Mirror Chestpiece,Satin-finish Black Tube |
| 00197998470561 - Littmann® Cardiology IV™ | 2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6242C, High Polish RainbowChestpiece, Satin-finish Navy Tube |
| 00197998470585 - Littmann® Cardiology IV™ | 2026-02-11 Littmann® Cardiology IV™ Stethoscope, 6159C, Stainless-finishChestpiece, Satin-finish Rose Pink Tube |
| 00197998154973 - Solventum™ Bair Hugger™ | 2026-02-09 Solventum™ Bair Hugger™ Warming Gown, 81001, Standard, 30/CS |
| 00197998154997 - Solventum™ Bair Hugger™ | 2026-02-09 Solventum™ Bair Hugger™ Warming Gown with Booties, 83001, Standard, 30/CS |