FDA.report

ITD

Primary DI
00840178701879
Brand
ITD
Company
Touchpoint Medical, Inc.
Model
KU.8050.903
Device description
Flexion-Port 300, ITD Support with Extension Arm
Published
2023-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications

CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840178701879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840178701879008401787018798401787018790840178701879

GMDN Terms

TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080434935
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
00840178704634ITDTP.5197.9992026-02-25
00840178704559ITDTP.5196.9992026-02-16
00840178704139ITDGF.8500.9202026-01-15
00840178704146ITDGF.8500.9212026-01-15
00840178704153ITDGF.8500.9272026-01-15
00840178704160ITDGF.8500.9282026-01-15
00840178704177ITDGF.8501.9202026-01-15
00840178704184ITDGF.8501.9212026-01-15
00840178704191ITDGF.8501.9272026-01-15
00840178704207ITDGF.8501.9282026-01-15
00840178704214ITDGF.5700.9202026-01-15
00840178704221ITDGF.5700.9212026-01-15
00840178704238ITDGF.5700.9272026-01-15
00840178704245ITDGF.5700.9282026-01-15
00840178704252ITDGF.5701.9202026-01-15
00840178704269ITDGF.5701.9212026-01-15
00840178704276ITDGF.5701.9272026-01-15
00840178704283ITDGF.5701.9282026-01-15
00840178704290ITDGF.5702.9202026-01-15
00840178704306ITDGF.5702.9212026-01-15

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06972077025917ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-19
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06972077025948ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-19
00840456218686JMUJMU DENTAL, INCBZN2026-03-11
00840456218693JMUJMU DENTAL, INCBZN2026-03-11
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G035046MLTACC0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-03-09
G035047MLTACC0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-03-09
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G035050MLTACC0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-03-09
G035051MLTACC0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-03-09