FDA.reportPublic FDA data

Sil-Flex

Primary DI
04710810083303
Brand
Sil-Flex
Company
GaleMed Xiamen Co., Ltd.
Model
77015
Device description
Sil-Flex tube 10F/22F，14cm
Published
2015-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24710810083307PackageGS150In Commercial Distribution
44710810083301PackageGS14In Commercial Distribution
04710810083303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2471081008330724710810083307
4471081008330144710810083301
04710810083303047108100833034710810083303

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit catheter mount, reusableA device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
527333326
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923980111907MindrayXMR00512026-05-26
06923980112546MindrayXMR00662026-05-26
06923980112577MindrayXMR00242026-05-26
06923980112584MindrayXMR00262026-05-26
06923980112591MindrayXMR01012026-05-26
06923980112607MindrayXMR01022026-05-26
06923980112614MindrayXMR00522026-05-26
06923980112621MindrayXMR00532026-05-26
06923980112638MindrayXMR00812026-05-26
06923980112690MindrayXMR01042026-05-26
06923980112799MindrayXMR00582026-05-26
06923980112805MindrayXMR00442026-05-26
06923980112829MindrayXMR00462026-05-26
06944904007236MindrayXMR00862026-05-26
16923980111843MindrayXMR02302026-05-26
06923980112522MindrayXMR00112026-05-25
06923980112539MindrayXMR00122026-05-25
06923980112553MindrayXMR00212026-05-25
06923980112560MindrayXMR00232026-05-25
06923980112645MindrayXMR00152026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
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