FDA.report

Medline

Primary DI
40080196714910
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NONFS400
Catalog number
NONFS400
Device description
SHIELD,FACE, 3/4",ELASTIC,FOAM TOP,LF
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FXXMask, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196714910PackageGS14In Commercial Distribution
30080196714913PrimaryGS10
10080196714919Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019671491040080196714910
3008019671491330080196714913
1008019671491910080196714919

GMDN Terms

TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
24
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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00810194402746AiraAIRA, LLCFXX2026-03-10
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
00068113110610EquateWAL-MART STORES, INC.FXX2026-02-25
10612479275932McKessonMCKESSON MEDICAL-SURGICAL INC.FXX2026-02-20
08809755250164KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
00810132808135House Brand DentistryFrontier Dental Supply IncFXX2026-02-10
30197344179750MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-29
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30197344153163MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-21
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00810194402692AiraAIRA, LLCFXX2026-01-16
00810194402708AiraAIRA, LLCFXX2026-01-16
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00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box BluePRACTICON, INC.FXX2026-01-08
00850025515092BAYLAB USABaylab USA, LLCFXX2026-01-05
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