FDA.report

Busse Hospital Disposables

Primary DI
00849233000223
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
6163R1
Catalog number
6163R1
Device description
Sterile Epidural Tray
Published
2016-09-23
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
10849233000220PackageGS110In Commercial Distribution
00849233000223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300022010849233000220
00849233000223008492330002238492330002230849233000223

GMDN Terms

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

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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