FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Concept Innovations (ACI)
DI: 00860005493210
·
Model: 3120
·
Advanced Concept Innovations, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Advanced Concept Innovations (ACI)
- Primary DI
- 00860005493210
- Version / Model
- 3120
- Company Name
- Advanced Concept Innovations, LLC
- Labeler DUNS
- 191062566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-11-16
- Public Version
- 2
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 865fce42-2a9b-4224-aaa2-b142a42b6a8b
Device Description
ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIOSH/FDA (TC-84A-9318), for use in healthcare settings. ACI’s Surgical N95 Respirator conforms to recognized standards for flammability, fluid resistance, and biocompatibility. Fluid resistance is a level 3, which is the highest level of protection (160 mm Hg).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSH | Respirator, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57794 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005493210 | GS1 | ||||
| Unit of Use | 00860005493203 | GS1 |