FDA.reportPublic FDA data

PRESSURE CONTROLLER COVER

Primary DI
00690103197891
Brand
PRESSURE CONTROLLER COVER
Company
Edwards Lifesciences LLC
Model
PCCVR
Catalog number
PCCVR
Device description
PRESSURE CONTROLLER COVER
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103197891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103197891006901031978916901031978910690103197891

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor/probe cover, non-sterileA non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06

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Primary DI, Brand, Company table
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09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
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