FDA.report

TUBE MANAGEMENT CLIP SYSTEM

Primary DI
05030267092307
Brand
TUBE MANAGEMENT CLIP SYSTEM
Company
INTERSURGICAL INCORPORATED
Model
2316000
Device description
TUBE MANAGEMENT CLIP SYSTEM
Published
2021-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZAConnector, Airway (Extension)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267092307PackageGS112In Commercial Distribution
05030267092314PackageGS148In Commercial Distribution
05030267092291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267092307050302670923075030267092307
05030267092314050302670923145030267092314
05030267092291050302670922915030267092291

GMDN Terms

TermDefinition
Breathing circuit tube holderA device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
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0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
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0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

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