FDA.report

Curaplex

Primary DI
00812574020243
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-005-10010
Device description
HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812574020243PackageGS150In Commercial Distribution
00812574025064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574020243008125740202438125740202430812574020243
00812574025064008125740250648125740250640812574025064

GMDN Terms

TermDefinition
Pleural drainage systemAn assembly of sterile devices intended to be used for the aspiration of air/fluid from the pleural cavity (potential space between the serous membranes covering the lungs) by means of suction. It includes a pleural catheter, a water seal (underwater) drainage unit, typically with three separate chambers, and typically a suction system regulator, intended to be connected to the hospital's central vacuum system; it does not include pharmaceuticals. This system is usually used to restore normal lung function following chest or mediastinal surgery (e.g., open heart surgery), or to treat conditions such as pneumothorax and/or haemothorax. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
010712461
Device count
1
DM exempt
false
Premarket exempt
true
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
true

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00812277034523Curaplex1712-108301712-108302019-07-01
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00812277034547Curaplex1712-158301712-158302019-07-01
00812277034554Curaplex1712-608301712-608302019-07-01
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00818834022316Curaplex301-181U301-181U2019-02-10
00818834022323Curaplex301-182U301-182U2019-02-10
00818834022354Curaplex301-189U301-189U2019-02-10
00818834022361Curaplex301-191U301-191U2019-02-10
00818834022378Curaplex301-192U301-192U2019-02-10
00818834021982Curaplex301-170EA301-170EA2019-02-10

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