IOB

GUDID 20850035767720

Iob Medical Inc.

Circulating-air whole-body heating system control unit
Primary Device ID20850035767720
NIH Device Record Key818cf068-e68c-4517-89bc-1e2b60efb332
Commercial Distribution StatusIn Commercial Distribution
Brand NameIOB
Version Model NumberIOB-022S
Company DUNS040239376
Company NameIob 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850035767726 [Primary]
GS120850035767720 [Package]
Contains: 00850035767726
Package: Case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-29
Device Publish Date2022-03-21

On-Brand Devices [IOB]

00850035767009IOB-505
20850035767997IOB-301
20850035767980IOB-302
20850035767973IOB-303
20850035767966IOB-304
20850035767935IOB-003
20850035767928IOB-002
00850035767917IOB-001
20850035767515IOB-001S
20850035767300IOB-030
20850035767294IOB-029
20850035767287IOB-028
00850035767252IOB-025
00850035767214IOB-021
20850035767201IOB-020
00850035767184IOB-018
20850035767164IOB-016
00850035767153IOB-015
20850035767140IOB-014
20850035767126IOB-012
20850035767102IOB-010
20850035767096IOB-009
20850035767089IOB-008
20850035767072IOB-007
20850035767065IOB-006
00850035767054IOB-005
20850035767041IOB-004
00850035767900IOB-301S
20850035767898IOB-302S
20850035767881IOB-303S
20850035767874IOB-304S
20850035767805IOB-030S
20850035767799IOB-029S
20850035767782IOB-028S
20850035767775IOB-027S
20850035767768IOB-026S
20850035767751IOB-025S
20850035767744IOB-024S
20850035767737IOB-023S
20850035767720IOB-022S
20850035767713IOB-021S
20850035767706IOB-020S
00850035767696IOB-019S
20850035767683IOB-018S
00850035767672IOB-017S
20850035767669IOB-016S
20850035767652IOB-015S
20850035767645IOB-014S
20850035767621IOB-012S
20850035767607IOB-010S

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