FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233016668
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
2350
Catalog number
2350
Device description
Personal Gown
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941845000BUSE STAFF PROTECTION GOWNS AND KITSBusse Hospital Disposables, Inc.1995-05-10FYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233016665PackageGS110In Commercial Distribution
00849233016668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301666510849233016665
00849233016668008492330166688492330166680849233016668

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags#

DUNS number
002418234
Device count
1
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
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00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
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