FDA.report

Site-Rite

Primary DI
00801741125362
Brand
Site-Rite
Company
Bard Access Systems, Inc.
Model
9770177R
Catalog number
9770177R
Device description
REFURB, SR VISION II TOWER
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IYNSystem, imaging, pulsed doppler, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741125362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741125362008017411253628017411253620801741125362

GMDN Terms

TermDefinition
General-purpose ultrasound imaging systemA 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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