CT KIT

GUDID 10816340023121

NEODEVICES INC

Single-administration urethral drainage catheter
Primary Device ID10816340023121
NIH Device Record Key0b0a8e75-59d5-44f0-a79e-30620ba94c34
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT KIT
Version Model NumberCT KIT
Company DUNS189670230
Company NameNEODEVICES 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816340023124 [Primary]
GS110816340023121 [Package]
Contains: 00816340023124
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GBMCatheter, Urethral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-17
Device Publish Date2023-02-09

Devices Manufactured by NEODEVICES INC

00816339023159 - SS-16602025-04-07 Blood Transfusion Shuttle Set
10816340023145 - Marian Medical2025-04-07 72” with a non-vented blood bag spike, a piece of tubing approximately 5”. Connected to a drip chamber with a 150µ filter,
10816340028355 - NeoDevices, Inc.2025-03-21 60” Enteral Extension set with Purple Enteral Locking Connectors (ISO 80369-3 compatible)
00816340023131 - SS-1660.132024-04-25 Blood Transfusion Shuttle Set
10816340027921 - NeoDevices, Inc.2023-12-04 Neonatal LP Needle 22ga x 1"
10816340027938 - NeoDevices, Inc.2023-12-04 Neonatal LP Needle 22ga x 1.5"
10816340027808 - NeoDevices, Inc.2023-06-02 Blood filter 17 micron
10816340023121 - CT KIT2023-02-17
10816340023121 - CT KIT2023-02-17

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