FDA UDI
In Commercial Distribution
🇺🇸 United States
Site-Rite
DI: 00801741104138
·
Model: 9770501R
·
Bard Access Systems, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Site-Rite
- Primary DI
- 00801741104138
- Version / Model
- 9770501R
- Catalog Number
- 9770501R
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 3
- Public Version Date
- 2018-05-23
- Public Version Status
- Update
- Public Device Record Key
- 3763e1fc-b37a-46b8-a044-db6afc1646cf
Device Description
SITE-RITE 8 ULTRASOUND SYSTEM W/ PHASER, US Refurbished
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, imaging, pulsed echo, ultrasonic | Radiology | 892.1560 | 2 |
| ITX | Transducer, ultrasonic, diagnostic | Radiology | 892.1570 | 2 |
| LLZ | System, image processing, radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741104135 | GS1 | CA | 1 | In Commercial Distribution | |
| Primary | 00801741104138 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Millimeter |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity