FDA.reportPublic FDA data

LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 mil

Primary DI
00616784802138
Brand
LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 mil
Company
Dynarex Corporation
Model
8021
Device description
Non-Sterile
Published
2025-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784802138PrimaryGS10
00810180841689Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784802138006167848021386167848021380616784802138
00810180841689008101808416898101808416890810180841689

GMDN Terms#

Term, Definition table
TermDefinition
Contaminated waste bagA flexible plastic pouch intended for the safe collection, storage, transportation and disposal of contaminated and/or otherwise hazardous biological materials, typically containing or having been in contact with bodily substances such as blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. It is typically identified with the biohazard symbol on its labelling and may be colour coded. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
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00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01
00616784206325Lab Coats Knitted Cuffs & Collar with Pockets, Medium, White20632021-09-01
00616784206424Lab Coats Knitted Cuffs & Collar with Pockets, Large, White20642021-09-01
00616784206523Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, White20652021-09-01
00616784206622Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White20662021-09-01
00616784207223Lab Coats Knitted Cuffs & Collar with Pockets, Small, Blue20722021-09-01
00616784207322Lab Coats Knitted Cuffs & Collar with Pockets, Medium, Blue20732021-09-01

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