FDA.report

Busse Hospital Disposables

Primary DI
00849233009684
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
164
Catalog number
164
Device description
12 Fr Frazier Suction Instrument
Published
2016-09-01
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
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10849233009681PackageGS110In Commercial Distribution
20849233009688PackageGS15In Commercial Distribution
00849233009684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300968110849233009681
2084923300968820849233009688
00849233009684008492330096848492330096840849233009684

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10849233014319Busse Hospital Disposables30392026-02-02
10849233014159Busse Hospital Disposables29812025-12-29
10849233014197Busse Hospital Disposables29822025-12-29
10849233014289Busse Hospital Disposables30352025-12-29
10849233014296Busse Hospital Disposables30302025-12-29
10849233014302Busse Hospital Disposables30442025-12-29
10849233014128Busse Hospital DisposablesB11452025-12-24
10849233014111Busse Hospital Disposables29672025-12-17
10849233014142Busse Hospital Disposables29802025-12-17
10849233014234Busse Hospital Disposables29852025-11-18
10849233014012Busse Hospital DisposablesB11462025-09-29
10849233014043Busse Hospital Disposables29462025-09-25
10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
00849233013162Busse Hospital DisposablesB84752025-05-01
10849233013121Busse Hospital DisposablesB84602025-04-23
10849233012834Busse Hospital DisposablesB17172025-03-20
10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00653405014952POOLEConmed CorporationGCX2026-03-24
50198956355475CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
50198956417999CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
G8057116571Bleed IDAPARATA MEDICAL, LLCGCX2026-03-02
50198956375640CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
50198956277937CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
20889483228743Muc-Away™SUNMED, LLCGCX2025-12-31
20889483228750Muc-Away™SUNMED, LLCGCX2025-12-31
20889483230111Muc-Away™SUNMED, LLCGCX2025-12-31
10889483230121Muc-Away™SUNMED, LLCGCX2025-12-31
50198956261806CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
50192253043363CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043370CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043387CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043394CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043400CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043417CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50198956252125CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
20816286021189Boehringer Surgical Suction DeviceBOEHRINGER LABORATORIES, LLCGCX2025-11-24
50198956160857CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
50198956180381CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
00194613008253MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019945MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019952MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021504MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021511MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021627MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021634MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021641MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021665MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01