Specimen Collection Swab SW0201

GUDID 00810050851862

Specimen Collection Swab - Oropharyngeal

TYPENEX MEDICAL LLC

Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab Oral/upper respiratory tract specimen collection swab
Primary Device ID00810050851862
NIH Device Record Keyce66ce34-9522-4583-b26f-e3d344b16c87
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecimen Collection Swab
Version Model NumberSW0201
Catalog NumberSW0201
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter
Length151 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050851848 [Primary]
GS100810050851862 [Package]
Contains: 00810050851848
Package: Case [200 Units]
In Commercial Distribution
GS110810050851869 [Package]
Package: Master Carton [20 Units]
In Commercial Distribution

FDA Product Code

KXGApplicator, Absorbent Tipped, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-07-22
Device Publish Date2020-06-01

On-Brand Devices [Specimen Collection Swab]

00810050852173Specimen Collection Swab - Oropharyngeal
00810050852135Specimen Collection Swab - Nasopharyngeal
00810050851930Specimen Collection Swab - Oropharyngeal
00810050851916Specimen Collection Swab - Nasopharyngeal
00810050851862Specimen Collection Swab - Oropharyngeal
00810049689988Specimen Collection Swab - Nasopharyngeal
00810050852685Oropharyngeal Swab - Spanish
00810050852678Nasopharyngeal Swab - Spanish
00810050852647Oropharyngeal Swab - Spanish
00810050852623Nasopharyngeal Swab
008100508526093" Polyester Swab
00810050852180Oropharyngeal Swab

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.