FDA.report

Busse Hospital Disposables

Primary DI
00849233000025
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
2907R2
Catalog number
2907R2
Device description
Universal Block Tray
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CAZAnesthesia Conduction Kit

Product Code Classifications

CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233000022PackageGS110In Commercial Distribution
00849233000025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300002210849233000022
00849233000025008492330000258492330000250849233000025

GMDN Terms

TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
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10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

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