FDA.reportPublic FDA data

CUSTOMED

Primary DI
M20890027812
Brand
CUSTOMED
Company
CUSTOMED INC
Model
712057052781
Catalog number
9002781
Device description
DISPOSABLE MUCUS TRAP, 80 ML (CC)
Published
2016-09-23
Public version status
Update
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
BYZTrap, Sterile Specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYZTrap, Sterile SpecimenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M20890027812PackageHIBCC50In Commercial Distribution
M20890027810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sputum specimen container IVDA covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume80Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT USE IF PACKAGE IS OPEN OR DAMAGED
Special Storage Condition, Specify00STORE IN A COOL DRY PLACE
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
787-622-5151customer.service@customedhealing.com

Regulatory Flags#

DUNS number
627572217
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2089004048C1CUSTOMED7120577000489004048C2023-08-10
M2089004049C1CUSTOMED7120577000499004049C2023-08-10
M2089004050C1CUSTOMED7120577000509004050C2023-08-10
M2089004051C1CUSTOMED7120577000519004051C2023-08-10
M20810063642CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029842CUSTOMED71205710298490029842023-08-10
M20890029852CUSTOMED71205710298590029852023-08-10
M20890029862CUSTOMED71205710298690029862023-08-10
M20890029872CUSTOMED71205710298790029872023-08-10
M20890029882CUSTOMED71205710298890029882023-08-10
M20890030922CUSTOMED71205710309290030922023-08-10
M20890030932CUSTOMED71205710309390030932023-08-10
M20890031442CUSTOMED71205710314490031442023-08-10
M20890040522CUSTOMED71205710405290040522023-08-10
M20890046941CUSTOMED71205701469490046942023-08-10
M20890046951CUSTOMED71205701469590046952023-08-10
M20810063640CUSTOMEDOR TURNOVER DRAPE WITH TRANSFER SHEET10063642023-08-10
M20890029840CUSTOMED71205710298490029842023-08-10
M20890029850CUSTOMED71205710298590029852023-08-10
M20890029860CUSTOMED71205710298690029862023-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04260647240382OsteoPointMorpheus AGBYZ2024-11-26
06975238202561CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2024-07-12
10192253024449ArgyleCardinal Health 200, LLCBYZ2024-02-14
50192253024447ArgyleCardinal Health 200, LLCBYZ2024-02-14
00852360007027Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
10852360007024Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
00852360007003Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM991Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
00860006413903Bone dust trapRIM Medical Technologies IncorporatedBYZ2022-07-10
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28
04260647240122Rebellion Tissue TrapMorpheus AGBYZ2022-06-27
10885632120343MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
50885632120341MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
10885632120336MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
50885632120334MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
00840117310377Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile Dynarex CorporationBYZ2021-04-22
00840117310384Mucus Specimen TrapDYNAREX CORPORATIONBYZ2021-04-22
10080196818624MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196999231MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196818625MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196999232MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196997411MEDLINEMEDLINE INDUSTRIES, INC.BYZ2020-10-28