FDA.reportPublic FDA data

NA

Primary DI
86974599110467
Brand
NA
Company
Changsha Magill Medical Technology Co., Ltd.
Model
STR-1
Device description
This device can be used with bronchial occluders and allow Magill Medical's Videoscope to visually monitor bronchial airway.
Published
2023-01-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
06974599110461PrimaryGS10
86974599110467Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974599110461069745991104616974599110461
8697459911046786974599110467

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
703075567
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
06974599110515NAMGL-FT-62023-01-13
06974599110522NAMGL-FT-C2023-01-13
06974599110539NAA82024-03-22
06974599110546NAB82024-03-22
06974599110447NAMGL-SP-C2022-08-23
06974599110003NAMGL-SP-62021-10-29
06974599110010NAMGL-VLMA-A1-#32021-10-29
06974599110027NAMGL-VLMA-A1-#42021-10-29
06974599110034NAMGL-VLMA-A1-#52021-10-29
06974599110454NAELB-12023-01-13
06974599110461NASTR-12023-01-13
06974599110478NATRI-22023-01-13
06974599110485NAEJT-12023-01-13
06974599110492NATRI-12023-01-13
06974599110508NAEXT-12023-01-13
86974599110450NAELB-12023-01-13
86974599110474NATRI-22023-01-13
86974599110481NAEJT-12023-01-13
86974599110498NATRI-12023-01-13
86974599110504NAEXT-12023-01-13

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00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
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14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
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