FDA.report

Busse Hospital Disposables

Primary DI
00849233000063
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
140
Device description
2 oz. Ear/Ulcer Bulb Syringe, Red
Published
2022-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications

CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849233000063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849233000063008492330000638492330000630849233000063

GMDN Terms

TermDefinition
Nasal aspirator, manualA portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
631-435-4711mail@busseinc.com

Regulatory Flags

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

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

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