Sunmed Inflation Device

GUDID 06947358568001

Sunny Medical Device (Shenzhen) Co., Ltd.

Catheter/overtube balloon inflator, single-use
Primary Device ID06947358568001
NIH Device Record Key3ba47d01-0690-4108-a787-b6583973bffd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunmed Inflation Device
Version Model NumberJ Type, 28ml, 40atm/bar
Company DUNS529639795
Company NameSunny Medical Device (Shenzhen) Co., Ltd.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106947358568001 [Primary]

FDA Product Code

PTMSyringe, Balloon Inflation, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-12
Device Publish Date2022-01-04

On-Brand Devices [Sunmed Inflation Device]

0694735856300630atm, 30ml
06947358568001J Type, 28ml, 40atm/bar
06947358566007J Type, 28ml, 30atm/bar

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