FDA.reportPublic FDA data

INSTAGARD

Primary DI
50192253061725
Brand
INSTAGARD
Company
Cardinal Health 200, LLC
Model
AT771212
Catalog number
AT771212
Device description
Pediatric Size Face Mask with Earloops
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OXZPediatric/child facemask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXZPediatric/Child FacemaskGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253061725PackageGS110In Commercial Distribution
20192253061724PrimaryGS10
10192253061727Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306172550192253061725
2019225306172420192253061724
1019225306172710192253061727

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
75
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056441261Target Up&UpTARGET CORPORATIONOXZ2026-06-25
20612479280919McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
40612479280920McKessonMCKESSON MEDICAL-SURGICAL INC.OXZ2026-02-26
00842942017490PRIMEDpriMED Medical Products IncOXZ2025-11-25
10842942017497PRIMEDpriMED Medical Products IncOXZ2025-11-25
00842942017452PRIMEDpriMED Medical Products IncOXZ2025-11-12
90842942017455PRIMEDpriMED Medical Products IncOXZ2025-11-12
00842942001888PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942003806PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942014314PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015267PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942015830PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016059PRIMEDpriMED Medical Products IncOXZ2025-07-14
00842942016066PRIMEDpriMED Medical Products IncOXZ2025-07-14
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10842942003803PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942014311PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015264PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942015837PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016056PRIMEDpriMED Medical Products IncOXZ2025-07-14
10842942016063PRIMEDpriMED Medical Products IncOXZ2025-07-14
10686864058592Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
20686864058599Medicom SafeMaskAMD Medicom IncOXZ2025-01-23
10810141931227VIVIT SupplyVivit Supply LLCOXZ2023-12-15
20810141931224VIVIT SupplyVivit Supply LLCOXZ2023-12-15
10810141930893VIVIT SupplyVivit Supply LLCOXZ2023-09-15
20810141930890VIVIT SupplyVivit Supply LLCOXZ2023-09-15
10842942015974CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOXZ2023-09-12
20192253061724INSTAGARDCardinal Health 200, LLCOXZ2023-07-12
00850022550249American Kid Disposable Face MaksArmbrust Inc.OXZ2023-01-27