FDA.reportPublic FDA data

Cranberry

Primary DI
10817508022994
Brand
Cranberry
Company
ASCEND EAGLE INCORPORATED
Model
S3160W
Device description
Cranberry S3+ ASTM 3 Face Mask 50 /BX , White
Published
2022-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817508022991PackageGS18In Commercial Distribution
10817508022994PrimaryGS10
00817508022997Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081750802299120817508022991
1081750802299410817508022994
00817508022997008175080229978175080229970817508022997

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 designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7075536190jordan.lim@pro2s.com

Regulatory Flags#

DUNS number
167102750
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817508022291CranberryCR39062025-09-02
10817508022321CranberryCR39072025-09-02
10817508023137CranberryCR39082025-09-02
10817508023861CranberryCR39092025-09-02
10817508022260CranberryCR39052025-09-02
20817508022298CranberryCR39062025-09-02
20817508022328CranberryCR39072025-09-02
20817508023134CranberryCR39082025-09-02
20817508023868CranberryCR39092025-09-02
10817508020082CranberryCR35752025-05-08
10817508020211CranberryCR35762025-05-08
10817508020327CranberryCR35772025-05-08
10817508020372CranberryCR35782025-05-08
10817508021713CranberryCR35792025-05-08
20817508020089CranberryCR35752025-05-08
20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
10817508021249BeesureBE13222022-05-24

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Primary DI, Brand, Company table
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10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
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00850084857331MedClickMedClick LLCLZA2026-07-22
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