10MM FLEXTUBE B/S WITH NEONATAL WATER TRAPS, MONITORING LINE AND 0.5M LIMB, 1.6M

Primary DI
05030267046768
Brand
10MM FLEXTUBE B/S WITH NEONATAL WATER TRAPS, MONITORING LINE AND 0.5M LIMB, 1.6M
Company
INTERSURGICAL INCORPORATED
Model
4510000
Device description
10MM FLEXTUBE B/S WITH NEONATAL WATER TRAPS, MONITORING LINE AND 0.5M LIMB, 1.6M
Published
2021-10-15
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05030267046768PackageGS115In Commercial Distribution
05030267067589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267046768050302670467685030267046768
05030267067589050302670675895030267067589

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
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05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
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0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
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0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
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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