CODMAN®

Primary DI
10381780520719
Brand
CODMAN®
Company
Integra LifeSciences Switzerland Sàrl
Model
826880
Catalog number
82-6880
Device description
CODMAN® Patient Monitor Interface Cable Draeger/Siemens (10 pin)
Published
2020-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, monitoring, intracranial pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152670000DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL2016-01-22GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780520719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178052071910381780520719

GMDN Terms#

Term, Definition table
TermDefinition
Physiological pressure monitor calibrator/cableA device intended to provide a reference signal to a pressure monitor (e.g., blood pressure monitor) for: 1) signal integrity/accuracy assessment; and/or 2) standardization of readings of physiological pressure signals [e.g., intracranial pressure (ICP), compartmental pressure]; it is not intended to imitate the signals the monitoring device receives during patient monitoring (i.e., not an electronic-signal simulator). It consists of an electronic or fibreoptic cable or small unit with input and output cables to make electrical or optical connections between a catheter connection cable and the patient monitor. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Waste Electrical and Electronic Equipment
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
480186617
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780520610DirectLink™82684082-68402020-04-01
10381780520726CODMAN®82688182-68812020-04-01
10381780520733CODMAN®82688282-68822020-04-01
10381780542247CODMAN®9190001GF9190001GF2026-04-15
10381780521433Codman VersaTru™9007050ST9007050ST2020-06-02
10381780521457Codman VersaTru™9007100ST9007100ST2020-06-02
10381780521495Codman VersaTru™9008050SL9008050SL2020-06-02
10381780521518Codman VersaTru™9008050ST9008050ST2020-06-02
10381780521532Codman VersaTru™9008100SL9008100SL2020-06-02
10381780521556Codman VersaTru™9008100ST9008100ST2020-06-02
10381780521570Codman VersaTru™9008150SL9008150SL2020-06-02
10381780521631Codman VersaTru™9009050ST9009050ST2020-06-02
10381780521655Codman VersaTru™9009100SL9009100SL2020-06-02
10381780521693Codman VersaTru™9009150SL9009150SL2020-06-02
10381780521716Codman VersaTru™9009150ST9009150ST2020-06-02
10381780521471Codman VersaTru™9007150ST9007150ST2020-06-02
10381780521594Codman VersaTru™9008150ST9008150ST2020-06-02
10381780521617Codman VersaTru™9009050SL9009050SL2020-06-02
10381780521679Codman VersaTru™9009100ST9009100ST2020-06-02
10381780250173Licox®CC1P1CC1P12016-08-04

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