FDA.reportPublic FDA data

Quick Pressure Monitor Set (Japan) - 20G

Primary DI
00850007350192
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
116981210
Device count
6
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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