FDA.report

Busse Hospital Disposables

Primary DI
00849233003729
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
1295
Catalog number
1295
Device description
Epidural Tray
Published
2020-04-07
Public version status
New
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
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849233003729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849233003729008492330037298492330037290849233003729

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
false
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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