FDA Device Registration & Listing · Brookings, SD, US · Registration 3031757047
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| QBP | Cap, Device Disinfectant | General Hospital | Class 2 | 880.5440 | 2019-04-01 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2004-01-28 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-07-15 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2007-12-06 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2009-11-24 |
| KGY | Bag, Intestine | General, Plastic Surgery | Class 1 | 878.4100 | 2004-01-28 |
| EYY | Drape, Urological, Disposable | General, Plastic Surgery | Class 2 | 878.4370 | 2020-07-07 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2025-07-10 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2025-12-18 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2024-10-29 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-05-22 |
| QBP | Cap, Device Disinfectant | General Hospital | Class 2 | 880.5440 | 2021-04-19 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2007-12-05 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2020-04-24 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2013-03-26 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2017-12-13 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | General, Plastic Surgery | Class 2 | 878.4370 | 2020-07-07 |
| QBP | Cap, Device Disinfectant | General Hospital | Class 2 | 880.5440 | 2019-04-01 |
| PEZ | Central Venous Catheter Dressing Change Kit | General Hospital | Class 2 | 880.5200 | 2014-12-12 |
| PLY | Antimicrobial Drapes | General, Plastic Surgery | Class 2 | 878.4370 | 2024-07-10 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2024-07-10 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2004-01-28 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | General Hospital | Class 2 | 880.2800 | 2022-09-06 |
| GYB | Media, Electroconductive | Neurology | Class 2 | 882.1275 | 2007-12-06 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2025-07-21 |
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4760 | 1995-03-03 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2024-11-19 |
| SEL | Securement Wound Dressing For Reduction Of Infection | Unknown | Class U | N/A | 2019-11-21 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2004-01-28 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004943440 | 3M Purification, S. de R.L. de C. V. | San Luis Potosi Mexico, MX |
| 3003775292 | KCI POLYMEDICS BV | PEER Limburg, BE |
| 3036108847 | Solventum US LLC | Eden Prairie, MN, US |
| 3038988287 | Solventum Canada Limited | Morden Manitoba, CA |
| 3032763783 | Solventum Poland Manufacturing SP. ZO.O | Wroclaw Dolnoslaskie, PL |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K151482 | Bcr Diagnostics, Inc. | BCR-30-min BI and RBIP-ST30 Readout Accessory | 2016-02-26 |
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| K915446 | Sun Glitz Corp. | STRETCH WRAP | 1992-05-06 |
| K833120 | Acme United Corp. | ONE TIME COMPOUND BENZOIN TINCTURE- | 1983-12-29 |
| K870091 | Avery Intl. | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | 1987-02-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-06 | B. Braun Medical, Inc. | U | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. |
| Z-0038-2025 | 3M Company Health Care Business 3m Center | U | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R |
| Z-0027-2007 | N/A | 2 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. |
| Z-0013-2019 | COVIDIEN LLC | 1 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| Z-0014-2019 | COVIDIEN LLC | 1 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013319212 | ICU MEDICAL, INC. | Lake Forest, IL, US |
| 1713468 | ICU MEDICAL, INC | Salt Lake City, UT, US |
| 1423662 | Sterigenics US LLC | Gurnee, IL, US |
| 3036497156 | Solventum US LLC | Columbia, MO, US |
| 3010882065 | HEALTH LINE INTERNATIONAL CORPORATION | Salt Lake City, UT, US |
3031757047 when referencing this establishment in official correspondence.