FDA.report

Curaplex

Primary DI
00818834020022
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-T103
Catalog number
301-T103
Device description
TEE,VALVED,PED,15MM OD/ID,DISP,30/BX 12BX/CA
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Product Code Classifications

CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818834020015PackageGS130In Commercial Distribution
00818834020022PackageGS112In Commercial Distribution
00818834020008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818834020015008188340200158188340200150818834020015
00818834020022008188340200228188340200220818834020022
00818834020008008188340200088188340200080818834020008

GMDN Terms

TermDefinition
Mechanical positive pressure airway secretion-clearing deviceA hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, typically causing a high-density stainless steel ball to rapidly fluctuate up and down to create vibrations in the chest wall which loosens the mucus for expectoration and also assists in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
010712461
Device count
1
DM exempt
true
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
false

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00818834022378Curaplex301-192U301-192U2019-02-10
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