MBD-BL-BA-2

GUDID 26932503523060

the balloon diameter is 8-9-10mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guid

Micro-Tech (Nanjing) Co., Ltd.

Oesophageal balloon catheter Oesophageal balloon catheter
Primary Device ID26932503523060
NIH Device Record Key43a31f97-76eb-4b38-a617-78e9993c24f7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberMBD-BM-BA-2
Catalog NumberMBD-BL-BA-2
Company DUNS530269083
Company NameMicro-Tech (Nanjing) Co., Ltd.
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
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
GS116932503523063 [Primary]
GS126932503523060 [Package]
Contains: 16932503523063
Package: case [1 Units]
In Commercial Distribution

FDA Product Code

KNQDilator, Esophageal

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 Date2016-03-01

Devices Manufactured by Micro-Tech (Nanjing) Co., Ltd.

16932503563700 - MT2024-02-19 Minimum Required Working Channel :4.2mm,Minimum Working Channel Width:2.0mm
16932503563762 - MT2024-02-19 Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm
16932503513705 - MT2023-12-08 TPU, Double pigtails,7Fr,5cm
16932503513712 - MT2023-12-08 TPU, Double pigtails,7Fr,7cm
16932503513729 - MT2023-12-08 TPU, Double pigtails,7Fr,10cm
16932503513736 - MT2023-12-08 TPU, Double pigtails,7Fr,12cm
16932503513743 - MT2023-12-08 TPU, Double pigtails,7Fr,15cm
16932503513750 - MT2023-12-08 TPU, Double pigtails,8.5Fr,3cm

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