FDA UDI
In Commercial Distribution
🇺🇸 United States
iCE boom and Pendant
DI: 00684706002829
·
Model: iCE - V-Series
·
Amico Clinical Solutions Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- iCE boom and Pendant
- Primary DI
- 00684706002829
- Version / Model
- iCE - V-Series
- Catalog Number
- LP-V-TM-1811-90-220A
- Company Name
- Amico Clinical Solutions Corp
- Labeler DUNS
- 243821688
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 1
- Public Version Date
- 2020-07-10
- Public Version Status
- New
- Public Device Record Key
- adb15af7-78d0-427a-8d5a-73187164c79e
Device Description
Spectra V+LP Electric Series Tandem Mounted - 1000-750, 1000-1000, 90KG 220V AUS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35630 | General utility supply system, ceiling-mounted | An assembly of devices that form a permanent ceiling-mounted system that provides easy access to utilities/amenities (e.g., electricity, gas, or gas scavenging). It is used in the operating room (OR), examination rooms, the recovery department, the intensive care unit (ICU), and accident and emergency (A&E) rooms. It typically consists of a ceiling fixture support, equipped with moveable arms (often multi-jointed) and a pendant head. It can include an equipment carrier for mounting other medical devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00684706002829 | GS1 |
Customer Contacts
- Phone
- (905) 764-0800
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity