FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233011359
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
3272
Catalog number
3272
Device description
Single Shot Epidural Tray
Published
2016-09-13
Public version status
Update
Distribution status
Not 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
CAZAnesthesia Conduction Kit
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2
OGJNerve Block TrayAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063018000GLASS LOSS OF RESISTANCE SYRINGEBusse Hospital Disposables, Inc.2007-01-22CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233011356PackageGS110In Commercial Distribution
00849233011359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301135610849233011356
00849233011359008492330113598492330113590849233011359

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002418234
Device count
1
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
00849233003774Busse Hospital DisposablesB1329B13292020-06-25
00849233012066Busse Hospital Disposables975497542020-04-08
00849233012691Busse Hospital Disposables27432024-09-13
00849233014053Busse Hospital Disposables30152025-10-01
00849233003781Busse Hospital DisposablesB1330B13302020-07-10
00849233005112Busse Hospital DisposablesB1324B13242020-10-20
00849233011847Busse Hospital DisposablesB19302023-08-24
00849233018099Busse Hospital Disposables40422026-08-14
00849233017511Busse Hospital DisposablesB20862026-07-21
00849233017528Busse Hospital DisposablesB20282026-07-21
00849233017344Busse Hospital DisposablesB17122026-06-25
00849233017375Busse Hospital DisposablesB17132026-06-25
00849233014329Busse Hospital Disposables30342026-03-25
00849233017948Busse Hospital Disposables30922026-06-23
00849233013797Busse Hospital Disposables9792026-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956597761CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-10-15
10198956569782CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-10-12
10198956576025CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-10-12
10801902228045ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228052ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228069ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228076ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228083ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228090ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228106ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10198956579828CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-10-06
10198956563322CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-29
B098AMS196900Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-09-25
10198956571822CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-22
10198956541917CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956564176CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-09-21
10198956509498CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
10198956561878CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-08-26
00193493001088SINGLE SHOT EPIDURAL TRAYAvanos Medical, Inc.CAZ2026-08-21
B098AMS190500Aligned Medical SolutionsAligned Medical SolutionsOGJ2026-08-21
04046955966370Design Options®B. BRAUN MEDICAL INC.OGJ2026-08-17
00849233018099Busse Hospital DisposablesROBERT BUSSE & CO., INC.OGJ2026-08-14
10198956516755CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10198956533219CARDINAL HEALTHCardinal Health 200, LLCOGJ2026-07-31
10801902209471ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
10801902217193ARROWTELEFLEX INCORPORATEDCAZ2026-07-29