FDA.report

Leakbuster

Primary DI
00840165400815
Company
Pretium Canada Packaging ULC
Model
B1202-1O
Device description
Specimen Container, 120 ml, Orange Cap, Sterile.
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
246665038
Device count
75
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00840165400815PackageGS14In Commercial Distribution
00840165400808PrimaryGS10
10840165400805Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00840165400815PackageGS1400840165400808In Commercial Distribution
00840165400808PrimaryGS10
10840165400805Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMHContainer, Specimen, Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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00840165400532Starswab Multitrans SystemS160-FL-COM2025-02-21
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