FDA UDI
In Commercial Distribution
🇺🇸 United States
C.D.RICH
DI: 16935238804100
·
Model: PA 8cm
·
Chengdu Rich Science Industry Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- C.D.RICH
- Primary DI
- 16935238804100
- Version / Model
- PA 8cm
- Company Name
- Chengdu Rich Science Industry Co., Ltd.
- Labeler DUNS
- 724353334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 1
- Public Version Date
- 2022-12-13
- Public Version Status
- New
- Public Device Record Key
- cd89cfef-582d-440e-8d47-7529dc710cc1
Device Description
A swab consists of a swab stick and a swab tip. The swab stick is made from ABS. The swab tip is made from polyamide fiber (Nylon) .The product is applicable to the collection of human respiratory tract specimen and mouth mucosa specimen.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26935238804107 | GS1 | Carton | 10000 | In Commercial Distribution | |
| Primary | 16935238804100 | GS1 | ||||
| Unit of Use | 06935238804103 | GS1 |