FDA UDI
In Commercial Distribution
🇺🇸 United States
Nebulizer Kit
DI: 06973401840022
·
Model: OWWHQ-1901PT(408D)
·
Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nebulizer Kit
- Primary DI
- 06973401840022
- Version / Model
- OWWHQ-1901PT(408D)
- Company Name
- Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.
- Labeler DUNS
- 550888712
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-16
- Public Version
- 1
- Public Version Date
- 2020-07-24
- Public Version Status
- New
- Public Device Record Key
- 9f9be176-c557-41f6-b8d9-5d9f65462ac6
Device Description
Nebulizer Machine Mask parts, cool mist inhaler accessories tubing, mask kit, including tunbing (74 inch), mask for kids, mask for adult, mouthpiece by only warm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31309 | Nebulizing system delivery set, single-use | A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973401840022 | GS1 |