Home GUDID 10816340023121 CT KIT
Primary DI 10816340023121
Brand CT KIT
Company NEODEVICES INC
Model CT KIT
Published 2023-02-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GBM Catheter, Urethral
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GBM Catheter, Urethral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816340023121 Package GS1 5 In Commercial Distribution 00816340023124 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10816340023121 10816340023121 00816340023124 00816340023124 816340023124 0816340023124
GMDN Terms# Term, Definition table Term Definition Single-administration urethral drainage catheter A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.
Regulatory Flags# DUNS number 189670230 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816340021632 EL-SPIKE-M EL-SPIKE-M 2026-06-01 00816340021649 EL-SPIKE-F EL-SPIKE-F 2026-06-01 00816340021656 EL-S55-HF EL-S55-HF 2026-06-01 00816340023162 Transfer Straw ND-S55 2026-02-05 10816340023145 Marian Medical ETT-A-1550 2025-03-28 10816340021523 NeoDevices, Inc. ND60-EL 2016-09-24 10816340028355 NeoDevices, Inc. ND60-EL 2016-09-24 00816340023131 SS-1660.13 SS-1660.13 2024-04-17 10816340021097 NeoDevices, Inc. LN2210 2016-09-24 10816340021103 NeoDevices, Inc. LN2215 2016-09-24 10816340027921 NeoDevices, Inc. LN2210 2016-09-24 10816340027938 NeoDevices, Inc. LN2215 2016-09-24 10816340022117 NeoDevices, Inc. ND-BF20 2016-09-24 10816340027808 NeoDevices, Inc. ND-BF20 2016-09-24 00816340023124 CT KIT CT KIT 2023-02-09 10816340023008 NeoDevices, Inc. ND-S3EL 2016-09-24 10816340023015 NeoDevices, Inc. ND-S5EL 2016-09-24 10816340023022 NeoDevices, Inc. ND-S10EL 2016-09-24 10816340023039 NeoDevices, Inc. ND-S20EL 2016-09-24 10816340023046 NeoDevices, Inc. ND-S30EL 2016-09-24
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