FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233013766
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
976
Device description
"Safety-Deluxe Amniocentesis Tray with 20Gauge x 3 1/2"" Spinal Needle"
Published
2023-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIOSampler, Amniotic Fluid (Amniocentesis Tray)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIOSampler, Amniotic Fluid (Amniocentesis Tray)Obstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233013763PackageGS110In Commercial Distribution
00849233013766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301376310849233013763
00849233013766008492330137668492330137660849233013766

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, medicated, single-useA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, dressings, and pharmaceuticals. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
631-435-4711mail@busseinc.com

Regulatory Flags#

DUNS number
002418234
Device count
1
Premarket exempt
true
Kit
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
00849233010277Busse Hospital Disposables949794972020-04-02
00849233010376Busse Hospital Disposables954595452020-04-03
00849233004481Busse Hospital Disposables249124912016-09-20
00849233017276Busse Hospital Disposables40432026-05-28
00849233015906Busse Hospital DisposablesB84822026-05-27
00849233016538Busse Hospital Disposables40122026-05-21
00849233016958Busse Hospital Disposables40172026-05-21
00849233003750Busse Hospital DisposablesB1326B13262020-06-25
00849233003767Busse Hospital DisposablesB1328B13282020-06-25
00849233005129Busse Hospital DisposablesB1435B14352020-10-20
00849233014350Busse Hospital Disposables29112026-04-27
00849233014817Busse Hospital Disposables29602026-04-27
00849233000193Busse Hospital Disposables6007R16007R12016-09-14
00849233006256Busse Hospital Disposables173917392021-08-18
00849233011304Busse Hospital Disposables289328932016-09-13
00849233011359Busse Hospital Disposables327232722016-09-13
00849233011724Busse Hospital Disposables562156212016-09-13
00849233015036Busse Hospital Disposables356935692016-09-13
00849233015869Busse Hospital Disposables679067902016-09-13
00849233017733Busse Hospital Disposables679167912016-09-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50198956345971CARDINAL HEALTHCardinal Health 200, LLCHIO2026-03-03
10198956309418CARDINAL HEALTHCardinal Health 200, LLCHIO2025-12-26
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10198956251274CARDINAL HEALTHCardinal Health 200, LLCHIO2025-11-04
10198956224384CARDINAL HEALTHCardinal Health 200, LLCHIO2025-10-31
10198956063648CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
50198956063646CARDINAL HEALTHCardinal Health 200, LLCHIO2025-07-28
B098R404ROJFB0Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
B098R404ROJFB1Aligned Medical SolutionsAligned Medical SolutionsHIO2025-03-17
10197106799574CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
50197106799572CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-31
10197106781241CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
50197106781249CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-29
10197106784457CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
50197106784455CARDINAL HEALTHCardinal Health 200, LLCHIO2024-10-03
10197106704905CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
50197106704903CARDINAL HEALTHCardinal Health 200, LLCHIO2024-07-09
10197106602423CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
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50197106602421CARDINAL HEALTHCardinal Health 200, LLCHIO2024-04-16
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00191072215246ACSAMERICAN CONTRACT SYSTEMS, INC.HIO2024-01-12
10197106448694CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
50197106448692CARDINAL HEALTHCardinal Health 200, LLCHIO2023-12-19
10849233013763Busse Hospital DisposablesROBERT BUSSE & CO., INC.HIO2023-12-12
05060259071300AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05
25060259071304AmnicatorsMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDHIO2023-10-05