FDA.reportPublic FDA data

Premium Plus

Primary DI
D838601YELLOW2
Brand
Premium Plus
Company
Premium Plus International Limited
Model
601-YELLOW
Device description
Mouth Guard Box
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D838601YELLOW8PackageHIBCC20In Commercial Distribution
D838601YELLOW2PrimaryHIBCC0
D838601YELLOW0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, non-insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Regulatory Flags#

DUNS number
668367758
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83848982Premium Plus48982020-01-08
D8384604Premium Plus4602019-12-27
D8384704Premium Plus4702019-12-27
D8387460B4Premium Plus7460-B2019-12-27
D8387460G4Premium Plus7460-G2019-12-27
D8387460L4Premium Plus7460-L2019-12-27
D8387460R4Premium Plus7460-R2019-12-27
D8387460Y4Premium Plus7460-Y2019-12-27
D8387470B4Premium Plus7470-B2019-12-27
D8387470G4Premium Plus7470-G2019-12-27
D8387470L4Premium Plus7470-L2019-12-27
D8387470R4Premium Plus7470-R2019-12-27
D8387470Y4Premium Plus7470-Y2019-12-27
D8389062Premium Plus9062019-12-26
D8389072Premium Plus9072019-12-26
D83832202Premium Plus32202020-01-08
D83832252Premium Plus32252020-01-08
D838033LBLUE2Premium Plus033-LBLUE2020-01-08
D8381140BEIGE2Premium Plus1140-BEIGE2020-01-07
D8381140BLUE2Premium Plus1140-BLUE2020-01-07

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Primary DI, Brand, Company table
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10809160522387HalyardAVID MEDICAL, INC.NNI2026-06-02
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
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10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
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10840165500185HistoplexStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28