FDA.report

Specimen Container

Primary DI
00616784425627
Brand
Specimen Container
Company
DYNAREX CORPORATION
Model
4256
Device description
Specimen Containers, 4oz., Non-Sterile, Bulk Packed
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784425634PrimaryGS10
00616784425627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784425634006167844256346167844256340616784425634
00616784425627006167844256276167844256270616784425627

GMDN Terms

TermDefinition
24-hour urine specimen container IVD, no additiveA capped plastic receptacle, typically 2 to 4 litres, with no additives and intended to be used for the collection, and preservation and/or transport, of urine collected over a 24-hour period for analysis and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
500
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
true
Sterilization required before use
false

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