FDA.report

WM Nasopharyngeal Swab

Primary DI
D040702031
Brand
WM Nasopharyngeal Swab
Company
WHIP-MIX CORPORATION
Model
70203
Catalog number
70203
Device description
Whip Mix Nasopharyngeal Swab is a 3D printed device designed to collect test samples from patient.
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D040702031PrimaryHIBCC0

GMDN Terms

TermDefinition
Nasopharyngeal swabA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
006385173
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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