FDA UDI
In Commercial Distribution
🇺🇸 United States
Cliq Aspirator
DI: 04712946602557
·
Model: AS-1001D
·
ANEST IWATA SPARMAX Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cliq Aspirator
- Primary DI
- 04712946602557
- Version / Model
- AS-1001D
- Company Name
- ANEST IWATA SPARMAX Co., Ltd.
- Labeler DUNS
- 658285132
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2019-02-13
- Public Version Status
- Update
- Public Device Record Key
- 4d91b03e-0039-4786-b51b-7f0b9e4b246c
Device Description
Powered suction pump
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | 878.4780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10219 | Tracheal suction system | An assembly of devices designed to evacuate obstructive secretions, gas, liquids (e.g., blood, vomitus), and/or foreign bodies from the trachea. It generally consists of a mains electricity (AC-powered) suction pump, a pressure regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The typical vacuum level is from 80 to 120 mm Hg to reduce the risk of trauma; free flow rates may be higher than 25 L/min. The system is used to remove secretions and to maintain the airway of an intubated patient; it is mainly used when suction from a central vacuum system is not available or appropriate. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14712946602554 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 04712946602557 | GS1 |
Customer Contacts
- Phone
- +886223451868
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140031 | 000 |