FDA UDI
In Commercial Distribution
🇺🇸 United States
Venti.Plus
DI: 04710810100260
·
Model: 5405
·
GaleMed Xiamen Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Venti.Plus
- Primary DI
- 04710810100260
- Version / Model
- 5405
- Catalog Number
- H050-HD
- Company Name
- GaleMed Xiamen Co., Ltd.
- Labeler DUNS
- 527333326
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-19
- Public Version
- 5
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 78620e06-ba38-4358-9374-e88bd9cc13f2
Device Description
0.5 HYPERINFLATION W/ MANOMETER
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NHK | Resuscitator,Manual,Non Self-Inflating | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 44710810100268 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 04710810100260 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092687 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius