FDA.reportPublic FDA data

Quick Pressure Monitor Set (Japan) - 20G

Primary DI
20850007350042
Brand
Quick Pressure Monitor Set (Japan) - 20G
Company
C2DX, INC.
Model
0295-004-000J
Device description
Quick Pressure Monitor set (6/pk Chamber and side ported needle)
Published
2022-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXCMonitor, Pressure, Intracompartmental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXCMonitor, Pressure, IntracompartmentalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844214000COMPARTMENT SYNDROME PRESSURE MONITOR SYSStryker Corp.1985-04-04LXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850007350042PrimaryGS10
00850007350192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085000735004220850007350042
00850007350192008500073501928500073501920850007350192

GMDN Terms#

Term, Definition table
TermDefinition
Compartmental-pressure monitoring system, single-useAn assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., a prefilled syringe, one-way valves, and a side ported noncoring needle and/or slit catheter). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888-902-2239c2dx@c2dxinc.com

Regulatory Flags#

DUNS number
116981210
Device count
6
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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20850007350073Mul-T-Pad8002-062-0222024-01-09
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10850007350212SHAW SCALPEL7023-57102023-12-20

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