FDA.reportPublic FDA data

Rapid Response

Primary DI
10722066005122
Brand
Rapid Response
Company
BTNX Inc
Model
02MSK-50
Device description
Disposable Masks 50 pcs/kit
Published
2020-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10722066005122PrimaryGS10
00722066005125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072206600512210722066005122
00722066005125007220660051257220660051250722066005125

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Regulatory Flags#

DUNS number
251005005
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722066018009Rapid ResponseD13.5-1VA2026-07-14
10722066015053Rapid ResponseD12.49-1VAF2026-05-15
10722066015084Rapid ResponseD13.5-1VF2026-05-15
10722066011260Rapid ResponseD13.5-1VF2026-01-19
10722066011277Rapid ResponseD12.49-1VAF2026-01-19
20722066011267Rapid ResponseD13.5-1VF2026-01-19
20722066011274Rapid ResponseD12.49-1VAF2026-01-19
10722066011338Rapid ResponseFOB-9C36FOB-9C362026-01-02
20722066011335Rapid ResponseFOB-9C36FOB-9C362026-01-02
00722066000205Rapid ResponseHCG-3C50HCG-3C502016-10-25
00722066000267Rapid ResponseHCG-3C25HCG-3C252016-10-25
00722066004548Rapid ResponseD12.5-1V2019-01-21
10722066009083Rapid ResponseD12.49-1VA2025-10-03
10722066010973Rapid ResponseD13.5-1V2025-07-08
00722066010976Rapid ResponseD13.5-1V2025-07-08
10722066009601Rapid ResponseCOF-19CGHU22025-05-29
10722066009618Rapid ResponseCOF-19CGHU42025-05-29
10722066010751Rapid ResponseSTR-15SGPU-252025-05-29
10722066009595Rapid ResponseCOF-19CGHU12025-05-29
00722066009604Rapid ResponseCOF-19CGHU22025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09