FDA.reportPublic FDA data

SHENGJIE

Primary DI
06970614670309
Brand
SHENGJIE
Company
Weihai Shengjie Medical Technology Co., Ltd.
Model
M3
Device description
Oxygen Tube
Published
2026-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZBCatheter, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZBCatheter, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970614670309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970614670309069706146703096970614670309

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530242002
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
06970614670316SHENGJIEDD2026-03-02
06970614670323SHENGJIEDD2026-03-02
06970614670330SHENGJIEDD2026-03-02
06970614670347SHENGJIEM12026-03-02
06970614670354SHENGJIEM12026-03-02
06970614670361SHENGJIEM12026-03-02
06970614670378SHENGJIEM22026-03-02
06970614670385SHENGJIEM22026-03-02
06970614670392SHENGJIEM22026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501126CONNECTING CATHETER 12 2000ASSOMEDIKA, OOOBZB2026-05-19
04816415501133CONNECTING CATHETER 14 2000ASSOMEDIKA, OOOBZB2026-05-19
04816415501140OXYGEN CATHETER 16 2000ASSOMEDIKA, OOOBZB2026-05-19
06970614670316SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670323SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670330SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670347SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670354SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670361SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670378SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670385SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
06970614670392SHENGJIEWeihai Shengjie Medical Technology Co., Ltd.BZB2026-03-02
14026704656988HUDSON RCITELEFLEX INCORPORATEDBZB2019-05-09
24026704656985HUDSON RCITELEFLEX INCORPORATEDBZB2019-05-09
14026704616425HUDSON RCITELEFLEX INCORPORATEDBZB2018-09-15
04026704594511HUDSON RCITELEFLEX INCORPORATEDBZB2018-09-15
04026704594528HUDSON RCITELEFLEX INCORPORATEDBZB2018-09-15
34026704616429HUDSON RCITELEFLEX INCORPORATEDBZB2018-09-15