FDA UDI
In Commercial Distribution
🇺🇸 United States
MDHC
DI: 06974669350360
·
Model: 1 set/bag
·
MDHC Life Technologies (Kunshan) Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MDHC
- Primary DI
- 06974669350360
- Version / Model
- 1 set/bag
- Company Name
- MDHC Life Technologies (Kunshan) Co., LTD.
- Labeler DUNS
- 625685749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- a2ee5a54-999b-4f62-a353-ea45678835cb
Device Description
Disposable Intransal Atomization Device
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | 868.5640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65517 | Atomizer, ventilatory | A non-powered device intended to accept a medication canister and to be integrated within a mechanical or manual ventilation assembly (e.g., ventilator breathing circuit/endotracheal tube, pulmonary resuscitator) to provide liquid medication in aerosolized form for the patient to breathe during ventilation. It typically includes a medicine chamber spacer; unlike a nebulizer it lacks a baffle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974669350360 | GS1 |