FDA.reportPublic FDA data

XINYUANDING

Primary DI
86971092637620
Brand
XINYUANDING
Company
Shijiazhuang Yuanding Medical Device Co., LTD
Model
Type I, 1700mm
Catalog number
YDSI1700
Device description
Suction connection tube, Type I, 1700mm
Published
2024-03-06
Public version status
New
Distribution status
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
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971092637624PrimaryGS10
86971092637620Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971092637624069710926376246971092637624
8697109263762086971092637620

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1700Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560446074
Device count
100
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
06971092638096Sterile Oral Care Suction ToothbrushType AYDSAK2025-02-11
06971092638102Sterile Oral Care Suction ToothbrushType AYDSAP2025-02-11
06971092638119Sterile Oral Care Suction ToothbrushType BYDSBK2025-02-11
06971092638126Sterile Oral Care Suction ToothbrushType BYDSBP2025-02-11
16971092638093Sterile Oral Care Suction ToothbrushType AYDSAK2025-02-11
16971092638109Sterile Oral Care Suction ToothbrushType AYDSAP2025-02-11
16971092638116Sterile Oral Care Suction ToothbrushType BYDSBK2025-02-11
16971092638123Sterile Oral Care Suction ToothbrushType BYDSBP2025-02-11
06971092637976Yankauer HandleCrown top with holeYDSCH2025-02-10
06971092637983Yankauer HandleCrown top without holeYDSCW2025-02-10
06971092637990Yankauer HandleFlat top with holeYDSPH2025-02-10
06971092638003Yankauer HandleFlat top without holeYDSPW2025-02-10
06971092638157Non-sterile Oral Care Suction ToothbrushSuction typeYDAK2025-02-10
86971092637972Yankauer HandleCrown top with holeYDSCH2025-02-10
86971092637989Yankauer HandleCrown top without holeYDSCW2025-02-10
86971092637996Yankauer HandleFlat top with holeYDSPH2025-02-10
86971092638009Yankauer HandleFlat top without holeYDSPW2025-02-10
86971092638153Non-sterile Oral Care Suction ToothbrushSuction typeYDAK2025-02-10
06971092636702Suction Connection Tube with HandleCrown top with hole 1500mmYDSCH15002024-11-13
06971092636719Suction Connection Tube with HandleCrown top with hole 1700mmYDSCH17002024-11-13

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Primary DI, Brand, Company table
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10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
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