FDA UDI
In Commercial Distribution
🇺🇸 United States
Particulate Respirator
DI: 16946276000010
·
Model: GIKO 1400
·
Shanghai Gangkai Purifying Products Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Particulate Respirator
- Primary DI
- 16946276000010
- Version / Model
- GIKO 1400
- Company Name
- Shanghai Gangkai Purifying Products Co., Ltd.
- Labeler DUNS
- 653746735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 1
- Public Version Date
- 2024-03-04
- Public Version Status
- New
- Public Device Record Key
- 6546ccd8-375f-4ddf-888b-d8287fea4c63
Device Description
Particulate Respirator and Surgical Mask.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 06946276000013 | GS1 | ||||
| Primary | 16946276000010 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063334 | 000 |