Certa Catheter

Primary DI
05902194190350
Brand
Certa Catheter
Company
FERROSAN MEDICAL DEVICES SP Z O O
Model
R120C1
Device description
Certa Catheter™ continuous peripheral nerve block catheter set is indicated for deliveryof medication for regional anesthesia and pain management in lower extremity blocks.It may be used by a qualified healthcare professional in a perioperative monitoredcare setting.Certa Catheter™ is intended for use in adult patients only. It should always be insertedand placed under ultrasound guidance by a healthcare professional.The Certa Catheter has not been evaluated for use in upper extremity blocks.
Published
2018-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSOCatheter, Conduction, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902194190367PackageGS15Not in Commercial Distribution
05902194190374PackageGS160Not in Commercial Distribution
05902194190350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902194190367059021941903675902194190367
05902194190374059021941903745902194190374
05902194190350059021941903505902194190350

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
426737794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902194190299Certa CatheterR50C12018-02-21
05902194190329Certa CatheterR75C12018-02-21
05902194190381Certa CatheterR50D12018-02-21
05902194190411Certa CatheterR75D12018-02-21
05902194190442Certa CatheterR120D12018-02-21
05902194190312Certa CatheterR50C12018-02-21
05902194190343Certa CatheterR75C12018-02-21
05902194190374Certa CatheterR120C12018-02-21
05902194190404Certa CatheterR50D12018-02-21
05902194190435Certa CatheterR75D12018-02-21
05902194190466Certa CatheterR120D12018-02-21

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