Sil-Flex

GUDID 04710810083198

New Sil-Flex Silicone Mask size 3, Child Large

GaleMed Xiamen Co., Ltd.

Anaesthesia face mask, reusable
Primary Device ID04710810083198
NIH Device Record Keyb686b1c3-c85f-4a9c-96a9-da5cea5ee4f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSil-Flex
Version Model Number5181
Company DUNS527333326
Company NameGaleMed Xiamen Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104710810083198 [Primary]
GS124710810083192 [Package]
Package: Box [2 Units]
In Commercial Distribution
GS144710810083196 [Package]
Contains: 24710810083192
Package: Carton [12 Units]
In Commercial Distribution

FDA Product Code

BSJMask, Gas, Anesthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-19

On-Brand Devices [Sil-Flex]

44710810083301Sil-Flex tube 10F/22F,14cm
04710810083198New Sil-Flex Silicone Mask size 3, Child Large

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