Primary Device ID | 00197998028885 |
NIH Device Record Key | 6c3f95d6-91ca-4d39-83ba-6f11da5d6c05 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Solventum US LLC |
Version Model Number | STPASPEE |
Catalog Number | STPASPEE |
Company DUNS | 102726734 |
Company Name | KCI USA, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
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 | 00197998028885 [Primary] |
OKO | Negative pressure wound therapy non-powered suction apparatus |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-31 |
Device Publish Date | 2025-07-23 |
00197998028915 | Solventum™ Snap™ Plus Therapy Strap, STPALP, Large, 1/CS |
00197998028908 | Solventum™ Snap™ Plus Therapy Strap, STPASP, Small, 1/CS |
00197998028892 | Solventum™ Snap™ Therapy Strap, STPAL, Large, 1/CS |
00197998028885 | Solventum™ Snap™ Plus Therapy Strap, STPASPEE, Small, 1/CS |
00197998028878 | Solventum™ Snap™ Therapy Strap, STPASEE, Small, 1/CS |
00197998028861 | Solventum™ Snap™ Plus Therapy Strap, STPAMPEE, Medium, 1/CS |
00197998028854 | Solventum™ Snap™ Therapy Strap, STPAMEE, Medium, 1/CS |
00197998028847 | Solventum™ Snap™ Plus Therapy Strap, STPALPEE, Large, 1/CS |
00197998028830 | Solventum™ Snap™ Therapy Strap, STPALEE, Large, 1/CS |
00197998028823 | Solventum™ Snap™ Therapy Strap, STPAM, Medium, 1/CS |
00197998028816 | Solventum™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1/CS |
00197998028809 | Solventum™ Snap™ Therapy Strap, STPAS, Small, 1/CS |