OTI

GUDID 06978333140004

face mask Headstrap

Xiamen Oti Electronic Industry Co., Ltd.

Anaesthesia mask strap, reusable
Primary Device ID06978333140004
NIH Device Record Keya31c6757-19dc-4580-8a4b-97253ddf3d77
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTI
Version Model Number8151
Company DUNS528147084
Company NameXiamen Oti Electronic Industry Co., Ltd.
Device Count10
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn
Phone18950122603
Emailanita@otixm.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106978333140004 [Unit of Use]
GS106978333140011 [Primary]

FDA Product Code

BTKStrap, Head, Gas Mask

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-21
Device Publish Date2025-04-11

On-Brand Devices [OTI]

06978333140035face mask Headstrap
06978333140004face mask Headstrap

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