FDA.report

Curaplex

Primary DI
00817617020419
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-P3600EA
Device description
DIVIDED CANNULA,7'*,MLUER
Published
2016-12-16
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
CATCANNULA, NASAL, OXYGEN

Product Code Classifications

CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817617020419PackageGS125In Commercial Distribution
00812574025866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817617020419008176170204198176170204190817617020419
00812574025866008125740258668125740258660812574025866

GMDN Terms

TermDefinition
Basic nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.

Sterilization Methods

Method

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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00818834028400Curaplex301-12230301-122302020-11-30
00818834028424Curaplex301-0903301-09032020-11-30
00812277034509Curaplex1812-020011812-020012019-07-01
00812277034523Curaplex1712-108301712-108302019-07-01
00812277034530Curaplex1712-108351712-108352019-07-01
00812277034547Curaplex1712-158301712-158302019-07-01
00812277034554Curaplex1712-608301712-608302019-07-01
00818834022309Curaplex301-180U301-180U2019-02-10
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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20885632467452HalyardOWENS & MINOR DISTRIBUTION, INC.CAT2026-01-29
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00850077887079AERIS Airway - Female Luer KitAirway Innovations, Inc.CAT2026-01-08
20889483223014Montgomery DMESUNMED, LLCCAT2025-12-30
20197344162694CARINGMEDLINE INDUSTRIES, INC.CAT2025-11-27
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20197344161208MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161215MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161222MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
20197344161239MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
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