Certa Catheter

Primary DI
05902194190343
Brand
Certa Catheter
Company
FERROSAN MEDICAL DEVICES SP Z O O
Model
R75C1
Device description
Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171193000Certa CatheterFerrosan Medical Devices Sp. Z.O.O.2017-12-18BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05902194190336PackageGS15In Commercial Distribution
05902194190343PackageGS160In Commercial Distribution
05902194190329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05902194190336059021941903365902194190336
05902194190343059021941903435902194190343
05902194190329059021941903295902194190329

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheterA flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, and near peripheral nerves. It may include devices dedicated to catheter introduction/function (e.g., needle, sheath); it is not coated with an antimicrobial agent. This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
426737794
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05902194190299Certa CatheterR50C12018-02-21
05902194190329Certa CatheterR75C12018-02-21
05902194190350Certa CatheterR120C12018-02-21
05902194190381Certa CatheterR50D12018-02-21
05902194190411Certa CatheterR75D12018-02-21
05902194190442Certa CatheterR120D12018-02-21
05902194190312Certa CatheterR50C12018-02-21
05902194190374Certa CatheterR120C12018-02-21
05902194190404Certa CatheterR50D12018-02-21
05902194190435Certa CatheterR75D12018-02-21
05902194190466Certa CatheterR120D12018-02-21

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Primary DI, Brand, Company table
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