All Flow Valved Ex.Mthpc.

GUDID 10384620000761

ALLIANCE TECH MEDICAL INC

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use
Primary Device ID10384620000761
NIH Device Record Key03782cf9-c530-4c36-aa28-50163c0ff38e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Flow Valved Ex.Mthpc.
Version Model Number3122064
Company DUNS144713174
Company NameALLIANCE TECH MEDICAL INC
Device Count200
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100384620000764 [Primary]
GS110384620000761 [Unit of Use]

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-18
Device Publish Date2023-09-08

Devices Manufactured by ALLIANCE TECH MEDICAL INC

10384620000730 - InFloCone2023-09-18
10384620000754 - All Flow Valved Insp. Mthpc2023-09-18
10384620000761 - All Flow Valved Ex.Mthpc.2023-09-18
10384620000761 - All Flow Valved Ex.Mthpc.2023-09-18
10384620000778 - All Flow Adult Disp Mthpc.2023-09-18
10384620000785 - All Flow Peds Disp Mthpc.2023-09-18
10384620000792 - All Flow Mthpc. Adapter2023-09-18
10384620000808 - All Flow Resp. Disp. Mthpc.2023-09-18
10384620000815 - All Flow Thermoplastic Rbr Mthpc.2023-09-18

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