Revo Medical

GUDID 00850035252024

ASTM Level 3 Surgical Anti-Fog Film Mask, Surgical Ties, Green

Revo Medical Products Inc

Surgical/medical face mask, single-use
Primary Device ID00850035252024
NIH Device Record Key101e0a37-4aa7-49fa-bd67-a47394c4309e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevo Medical
Version Model NumberRM1790
Company DUNS118289620
Company NameRevo Medical Products Inc
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100850035252024 [Unit of Use]
GS100850035252130 [Primary]
GS100850035252246 [Package]
Contains: 00850035252130
Package: Case [6 Units]
In Commercial Distribution

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-23
Device Publish Date2021-12-15

On-Brand Devices [Revo Medical]

00850035252277ASTM Level 3 Surgical Soft Mask, Surgical Ties, White
00850035252321ASTM Level 3 Surgical Anti-Fog Tape Mask, Surgical Ties, Green
00850035252314ASTM Level 1 Procedure Mask, Earloop, Yellow
00850035252284ASTM Level 3 Procedure Soft Mask, Earloop, White
00850035252260ASTM Level 3 Surgical Duckbill Mask, Surgical Ties, Green
00850035252253ASTM Level 3 Surgical Anti-Fog Foam Mask, Surgical Ties, Iris
00850035252024ASTM Level 3 Surgical Anti-Fog Film Mask, Surgical Ties, Green
00850035252239ASTM Level 1 Procedure Mask, Earloop, Blue
00850035252000ASTM Level 3 Procedure Anti-Fog Foam Mask, Earloop, Iris

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