FDA.reportPublic FDA data

CORRUGATED TUBING

Primary DI
00612649100494
Brand
CORRUGATED TUBING
Company
King Systems Corporation
Model
101100
Catalog number
101100
Device description
TUBING,100' SEGMENTED COIL
Published
2022-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTUBING, PRESSURE AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649100494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649100494006126491004946126491004940612649100494

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
009299017
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612649196398ADULT ANESTHESIABREATHING CIRCUIT8403F-80Z8403F-80Z2016-09-22
00612649198552ADULT ANESTHESIA8600B-848600B-842020-10-21
00612649198651ADULT ANESTHESIABREATHING CIRCUIT8603F-6121Z8603F-6121Z2016-09-22
00612649198668ADULT ANESTHESIABREATHING CIRCUIT8603F-61Z8603F-61Z2016-09-22
00612649200033UNIVERSAL F2®C0120-230C0120-2302022-12-13
00612649200071UNIVERSAL F2®C060-230C060-2302023-01-16
00612649200118UNIVERSAL F2®C090-230C090-2302022-12-13
00612649200125UNIVERSAL F2®C090-61C090-612022-12-13
00612649200149UNIVERSAL F2®C360-61ZC360-61Z2022-12-13
00612649200323ADULT ANESTHESIABREATHING CIRCUITCP-01084CP-010842016-09-22
00612649200934UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD360-808ZD360-808Z2016-09-22
00612649201078UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD366-618ZD366-618Z2016-09-22
00612649201214UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-16421ZD395-16421Z2016-09-22
00612649201238UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-8021ZD395-8021Z2016-09-22
00612649201283UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-6121ZD440-6121Z2016-09-22
00612649201306UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-80ZD440-80Z2016-09-22
00612649201337UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD445-80ZD445-80Z2016-09-22
00612649201597UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465-80ZD465-80Z2016-09-22
00612649201610UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465V-8021ZD465V-8021Z2016-09-22
00612649201627UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD466-6121ZD466-6121Z2016-09-22

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