FDA.reportPublic FDA data

Oak Ridge Products

Primary DI
00852482006847
Brand
Oak Ridge Products
Company
OAKRIDGE PRODUCTS, LLC
Model
0401-1100
Device description
Container 4 OUNCE capacity, translucent, with lid, 250 pieces/carton, gross weight 8 lbs. Carton dimension: 16x16x8.
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
10852482006844PackageGS1250In Commercial Distribution
00852482006847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085248200684410852482006844
00852482006847008524820068478524820068470852482006847

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
815-363-4709QUALITY@OAKRIDGEPRODUCTS.COM

Regulatory Flags#

DUNS number
111322165
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852482006830Oak Ridge Products0105-01002023-09-20
00852482006823Oak Ridge Products0701-58002023-09-20
10852482006837Oak Ridge Products0105-01002023-09-20
00852482006410Oak Ridge Products0310-150T2016-09-22
00852482006502Oak Ridge Products0319-15002016-09-22
00852482006519Oak Ridge Products0319-150F2016-09-22
00852482006526Oak Ridge Products0330-15002016-09-22
00852482006533Oak Ridge Products0310-16002016-09-23
00852482006557Oak Ridge Products0330-150R2016-09-22
00852482006564Oak Ridge Products0320-150F2016-09-22
00852482006571Oak Ridge Products0311-150F2016-09-22
00852482006588Oak Ridge Products0319-150R2016-09-22
00852482006595Oak Ridge Products0320-150R2016-09-22
00865273000009Oak Ridge Products0322-150R2016-09-22
00865273000016Oak Ridge Products0310-15002016-09-22
00865273000023Oak Ridge Products0320-15002016-09-22
00865273000030Oak Ridge Products0354-150M2016-09-22
00865273000047Oak Ridge Products0354-150H2016-09-22
00865273000054Oak Ridge Products0354-150B2016-09-22
00865273000061Oak Ridge Products0354-110B2016-09-22

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