RiskWise Supplies
- Primary DI
- 00860014697302
- Brand
- RiskWise Supplies
- Company
- RiskWise Supplies LLC
- Model
- RSTK-IND
- Device description
- A convenience kit containing multiple legally marketed medical devices and over-the-counter drug products packaged together for consumer use, including respiratory protective equipment, temperature monitoring devices, and a diagnostic test, intended for general health preparedness and monitoring.
- Published
- 2026-02-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| MSH | Respirator, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MSH | Respirator, Surgical | General, Plastic Surgery | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860014697302 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00860014697302 | 00860014697302 | 860014697302 | 0860014697302 |
GMDN Terms
| Term | Definition |
|---|
| Surgical/medical respirator, non-antimicrobial, single-use | A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device. |
Regulatory Flags
- DUNS number
- 139565549
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860014697319 | RiskWise Supplies | RSTK-FAM | | 2026-02-17 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00817169029649 | Essentials By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | MSH | 2026-03-05 |
| 00860014697319 | RiskWise Supplies | RiskWise Supplies LLC | MSH | 2026-02-17 |
| 00044585817301 | Fastline | LOUIS M. GERSON CO. | MSH | 2025-04-14 |
| 10850019086154 | Altor Safety | LOUIS M. GERSON CO. | MSH | 2025-04-14 |
| 00850052096434 | Medava | LOUIS M. GERSON CO. | MSH | 2025-04-14 |
| 00781311086104 | SAS Safety / Gerson | Bunzl USA Holdings LLC | MSH | 2025-04-04 |
| 10016659570150 | All Pro | Bunzl USA Holdings LLC | MSH | 2025-04-04 |
| 00850017658264 | Lighthouse Worldwide Solutions Inc | Lighthouse Worldwide Solutions, Inc. | MSH | 2025-02-11 |
| 00850056748070 | FORWARD Enforcement Group Medical Bag | INTEGRATED MEDCRAFT LLC | MSH | 2024-10-04 |
| 30197344019537 | Medline | MEDLINE INDUSTRIES, INC. | MSH | 2024-03-27 |
| 10852212003693 | ProGear | PRESTIGE AMERITECH, LTD. | MSH | 2024-03-01 |
| 06946276000013 | Particulate Respirator | Shanghai Gangkai Purifying Products Co., Ltd. | MSH | 2024-02-23 |
| 00044585833301 | GERSON | LOUIS M. GERSON CO. | MSH | 2024-01-12 |
| 06924997807876 | Makrite Industries Inc. | DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD. | MSH | 2023-09-28 |
| 06924997809061 | Makrite Industries Inc. | DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD. | MSH | 2023-09-28 |
| 06924997819114 | Makrite Industries Inc. | DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD. | MSH | 2023-09-28 |
| 10860008614671 | AtlanticMED | Atlantic Trading LLC | MSH | 2023-09-08 |
| 16973875280741 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-21 |
| 16973875280758 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-21 |
| 16973875280765 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-21 |
| 06973875281017 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-14 |
| 06973875280072 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-14 |
| 06973875281000 | Makrite Industries Inc. | Makrite Hubei Industrial Co., Ltd. | MSH | 2023-07-06 |
| 06974669350223 | MDHC | MDHC Life Technologies (Kunshan) Co., LTD. | MSH | 2023-07-06 |
| 16973178959016 | Master& Frank | Dongguan Shin Yi Healthcare Products Factory | MSH | 2023-06-30 |
| 00686864059578 | MEDICOM SAFEMASK | AMD Medicom Inc | MSH | 2023-05-25 |
| 00850017658127 | Lighthouse Worldwide Solutions Inc | Lighthouse Worldwide Solutions, Inc. | MSH | 2023-02-27 |
| 00715912017106 | CareMates | Shepard Medical Products, Inc. | MSH | 2023-01-06 |
| 00044585917308 | GERSON | LOUIS M. GERSON CO. | MSH | 2023-01-03 |
| 00810084939307 | WeCare | Jeg & Sons Inc. | MSH | 2022-12-16 |
riskwisesupplies.com