FDA.report

Typenex Specimen Collection Swab

Primary DI
00810050852340
Brand
Typenex Specimen Collection Swab
Company
TYPENEX MEDICAL LLC
Model
SW0104XNY
Catalog number
SW0104XNY
Device description
Specimen Collection Swab - Nasopharyngeal - New York
Published
2020-08-11
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
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810050852357PackageGS1100In Commercial Distribution
10810050852354PackageGS11000In Commercial Distribution
00810050852340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810050852357008100508523578100508523570810050852357
1081005085235410810050852354
00810050852340008100508523408100508523400810050852340

GMDN Terms

TermDefinition
Nasopharyngeal swabA sterile device designed as a piece of absorbent material, with no additives, on a stick and intended to be used for the collection, and preservation and/or transport, of a clinical specimen from the nasopharynx for culture, analysis, and/or other investigation. This is a single-use device.

Device Sizes

TypeValueUnit
Length150Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
600850213
Device count
1
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
false
Sterilization required before use
false

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