FDA.report

Specimen Container- 4oz., Sterile

Primary DI
00616784425429
Brand
Specimen Container- 4oz., Sterile
Company
DYNAREX CORPORATION
Model
4254
Device description
Specimen Container- 4oz., Sterile, Individually Wrapped, Screw-On Leak-Resistant Lid, Tamper-Evident Seal; Bulk Packed
Published
2021-06-21
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

Product Codes

CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784425436PrimaryGS10
00616784425429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784425436006167844254366167844254360616784425436
00616784425429006167844254296167844254290616784425429

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
100
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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