GUDID 00385640000086

SUMMIT MEDICAL, INC.

Instrument/equipment drape, single-use, non-sterile
Primary Device ID00385640000086
NIH Device Record Key36dbc82e-7510-480e-9034-a7d8ee65a050
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSP-30250
Company DUNS965484699
Company NameSUMMIT MEDICAL, INC.
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100385640000086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-05

Devices Manufactured by SUMMIT MEDICAL, INC.

00385640083881 - INSTRUSAFE2024-11-19
00385640083898 - INSTRUSAFE2024-11-19
00385640083874 - INSTRUSAFE2024-11-18
00385640083836 - INSTRUSAFE2024-11-15
00385640083843 - INSTRUSAFE2024-11-15
00385640083850 - INSTRUSAFE2024-11-15
00385640083867 - INSTRUSAFE2024-11-15
00385640083805 - INSTRUSAFE2024-11-14

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