FDA.report

Cranberry

Primary DI
10817508022239
Brand
Cranberry
Company
ASCEND EAGLE INCORPORATED
Model
Q2860S
Device description
360™ Face Masks Exclusive non-woven Anti-Fog Cushion Reduces fogging of eve wear Level 3 Small Silver - Case
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817508022236PrimaryGS10
10817508022239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2081750802223620817508022236
1081750802223910817508022239

GMDN Terms

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

Contacts

PhoneEmail
7075536190jordan.lim@pro2s.com

Regulatory Flags

DUNS number
167102750
Device count
8
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
10817508022260CranberryCR39052025-09-02
20817508022298CranberryCR39062025-09-02
20817508022328CranberryCR39072025-09-02
20817508023134CranberryCR39082025-09-02
20817508023868CranberryCR39092025-09-02
20817508020089CranberryCR35752025-05-08
20817508020218CranberryCR35762025-05-08
20817508020324CranberryCR35772025-05-08
20817508020379CranberryCR35782025-05-08
20817508021710CranberryCR35792025-05-08
20817508023004ASAP205712022-07-07
20817508023028ASAP205722022-07-07
20817508023035ASAP205732022-07-07
20817508023059ASAP205742022-07-07
20817508023066ASAP205752022-07-07
20817508023226ASAP207112022-07-07
20817508023233ASAP207122022-07-07
20817508023240ASAP207132022-07-07
20817508023257ASAP207142022-07-07
20817508023264ASAP207152022-07-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810219420120American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-11
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
00810219420113American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
08057147052111MDU7023S UNIVET SRLLYU2026-03-02
G1493806305TBS DentalACME ENTERPRISE.LYU2026-03-02
G149TBSMH107TBS DentalACME ENTERPRISE.LYU2026-03-02
10810132043731HCSConcordance Healthcare Solutions LLCLYU2026-01-16
20810141933488VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933495VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933501VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933518VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933525VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933532VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933549VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933556VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933563VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933570VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933587VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933594VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933600VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933617VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933624VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933631VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933648VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933655VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933662VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933679VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933686VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933693VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933709VIVIT SupplyVivit Supply LLCLYU2025-09-18