FDA.reportPublic FDA data

RTMED

Primary DI
06971642801796
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
Flat type,Tie-on 17.5cm×9.5cm
Published
2022-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210518000Surgical Face MaskShandong Haidike Medical Products Co., Ltd.2021-06-14FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971642801796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642801796069716428017966971642801796

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550402542
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971642806500RTMED6-0 Cutting 3/8 9mm 45cm 2024-01-05
06971642806517RTMED6-0 Round Bodied 1/2 10mm 45cm2024-01-05
06971642806524RTMED6-0 Round Bodied 1/2 13mm 75cm2024-01-05
06971642806531RTMED6-0 Without Needle 150cm2024-01-05
06971642806548RTMED5-0 Cutting 3/8 12mm 75cm2024-01-05
06971642806555RTMED5-0 Round Bodied 1/2 13mm 75cm2024-01-05
06971642806562RTMED5-0 Without Needle 150cm 2024-01-05
06971642806579RTMED4-0 Reverse Cutting 3/8 16mm 75cm2024-01-05
06971642806586RTMED4-0 Reverse Cutting 3/8 19mm 75cm2024-01-05
06971642806593RTMED4-0 Round Bodied 1/2 20mm 75cm2024-01-05
06971642806609RTMED4-0 Without Needle 150cm 2024-01-05
06971642806616RTMED3-0 Cutting 3/8 19mm 75cm2024-01-05
06971642806623RTMED3-0 Cutting 3/8 24mm 75cm2024-01-05
06971642806630RTMED3-0 Reverse Cutting 3/8 26mm 75cm2024-01-05
06971642806647RTMED3-0 Round Bodied 1/2 20mm 75cm2024-01-05
06971642806654RTMED3-0 Round Bodied 1/2 24mm 75cm2024-01-05
06971642806661RTMED3-0 Without Needle 150cm 2024-01-05
06971642806678RTMED2-0 Reverse Cutting 3/8 26mm 75cm2024-01-05
06971642806685RTMED2-0 Cutting 3/8 30mm 75cm2024-01-05
06971642806692RTMED2-0 Cutting 3/8 35mm 75cm2024-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054870704BAYLAB USABaylab USA, LLCFXX2026-10-01
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07