FDA.reportPublic FDA data

XinjingProWellness™

Primary DI
16973881680030
Brand
XinjingProWellness™
Company
Tianjin Newtrans Technology Development
Model
1009-C
Published
2021-12-24
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
true

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
16973881680030PackageGS150In Commercial Distribution
26973881680037PackageGS1400In Commercial Distribution
06973881680033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697388168003016973881680030
2697388168003726973881680037
06973881680033069738816800336973881680033

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical suction system, vacuumAn assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527173399
Device count
1
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
false
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
26973881680143N/A1010-C2023-03-03
26973881680150N/A1007-E2023-03-03
26973881680167N/A1001-C2023-03-03
26973881680181N/A1003-C2023-03-03
26973881680198N/A1011-C2023-03-03
16973881680023XinjingProWellness™1010-C2021-12-24
16973881680047XinjingProWellness™1003-B2021-12-24
16973881680054XinjingProWellness™1005-B2021-12-24
16973881680061XinjingProWellness™1011-B2021-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850027043821Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00850027043838Precision Medical Inc.Precision Medical, Inc.KDQ2026-02-25
00650862199109AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199158AtriumAtrium Medical CorporationKDQ2026-02-10
20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
06970462546849Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
00860014577543GROWNSYOak Tech LLCKDQ2026-01-28
00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
00810116023769Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
00810116023752Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
10884389968079MEDLINEMEDLINE INDUSTRIES, INC.KDQ2025-11-28
06976358503880SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KDQ2025-09-17
34026704912194PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-17
10858276007707Polyp Trap single chamber bulkMicro-tech UsaKDQ2025-09-09
34026704911784PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
26944932721962Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
06944932726215Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
26944932726226Wellead Stone Collection BottleWell Lead Medical Co.,LtdKDQ2025-08-14
50749756394418DeRoyalDEROYAL INDUSTRIES, INC.KDQ2025-08-13
06976472080106Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080113Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080151Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25
06976472080168Nasal aspiratorShenzhen Dongjiang Technology Co., Ltd.KDQ2025-07-25