FDA.reportPublic FDA data

Curaplex

Primary DI
00812277036176
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
8600-01440
Catalog number
8600-01440
Device description
*Custom* Berry Blood Draw Kit
Published
2020-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CBTArterial blood sampling kit
GJETRAY, BLOOD COLLECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBTArterial Blood Sampling KitAnesthesiology1
GJETray, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810094571337PackageGS150In Commercial Distribution
00812277036176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810094571337008100945713378100945713370810094571337
00812277036176008122770361768122770361760812277036176

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, reusableA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
070556204
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199972000641Curaplex1015-471711015-471712026-10-15
00199972000672Curaplex1015-471721015-471722026-10-15
00199972000702Curaplex1015-471731015-471732026-10-15
00199972000733Curaplex1015-471741015-471742026-10-15
00199972000764Curaplex1015-471751015-471752026-10-15
00810094576615CuraplexSRxOD2SY-24-KITSRxOD2SY-24-KIT2024-03-30
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889483479407Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479414Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
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10889483479476Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479483Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479490Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483479506Atellica® VTR SyringesSUNMED, LLCCBT2023-06-30
10889483558249Pulset SUNMED, LLCCBT2023-06-30
10889483558256PulsetSUNMED, LLCCBT2023-06-30
10889483558263PulsetSUNMED, LLCCBT2023-06-30
10889483558270PulsetSUNMED, LLCCBT2023-06-30
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10889483558317PulsetSUNMED, LLCCBT2023-06-30
10889483558331PulsetSUNMED, LLCCBT2023-06-30
10653160358329MEDLINEMEDLINE INDUSTRIES, INC.CBT2023-01-30
10653160357629MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-12-20
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10653160355472MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-27
10653160355144CenturionCENTURION MEDICAL PRODUCTS CORPORATIONCBT2022-09-03
10653160355199MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-09-03
10653160354338MEDLINEMEDLINE INDUSTRIES, INC.CBT2022-07-22