FDA.reportPublic FDA data

TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX

Primary DI
00840682142724
Brand
TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10 BOX
Company
WIPRO GE HEALTHCARE PRIVATE LIMITED
Model
B1
Catalog number
2015827-001
Device description
TRANSDUCER BELT - BUTTON - SINGLE PATIENT USE - 10/BOX
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSDBinder, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682142724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682142724008406821427248406821427240840682142724

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, reusableA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
650140403
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103831COROMETRICS 170 SERIESMODEL 1722016-06-24
00840682103848COROMETRICS 170 SERIESMODEL 1712016-06-24
00840682103879COROMETRICS 170 SERIESMODEL 1742016-06-24
00840682104111N/ATOCO TRANSDUCER WATERTIGHT BUTTON2016-06-24
00840682104210N/AULTRASOUND TRANSDUCER WATERTIGHT BUTTON2016-06-24
00840682104227NATOCO TRANSDUCER WATERTIGHT LOOP2016-06-24
00840682104296N/AULTRASOUND TRANSDUCER WATERTIGHT LOOP2016-06-24
00840682116367COROMETRICS 250CX SERIESMODEL 259CX2016-06-24
00840682117081Mini Telemetry System2051444-0022016-06-24
00840682117111Mini Telemetry System2051444-0032016-06-24
00840682117173Mini Telemetry System2051444-0012016-06-24
00840682142564ULTRASOUND TRANSDUCERNA21083462018-11-01
00840682142571TOCO TRANSDUCERNA21083472018-11-01
00840682143240Coro - Round MECG cable AHAMECG12018-10-29
00840682116992Mini Telemetry System2051444-0042016-06-24
00840682117012Mini Telemetry System2051440-0032016-06-24
00840682117067Mini Telemetry System2051440-0042016-06-24
00840682117128Mini Telemetry System2051440-0022016-06-24
00840682117166Mini Telemetry System2051440-0012016-06-24

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Primary DI, Brand, Company table
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