FDA.reportPublic FDA data

Canister

Primary DI
86971092632908
Brand
Canister
Company
Shijiazhuang Yuanding Medical Device Co., LTD
Model
PE15
Catalog number
YDPE15
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971092632902PrimaryGS10
86971092632908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971092632902069710926329026971092632902
8697109263290886971092632908

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1500Milliliter

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
15
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
Primary DIBrandCompanyProduct codePublished
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10192253002652Thora-SealCardinal Health 200, LLCKDQ2025-02-19
10192253002645Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002669Thora-SealCardinal Health 200, LLCKDQ2025-02-18
10192253002676ArgyleCardinal Health 200, LLCKDQ2025-02-18
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