FDA.report

Bausch + Lomb

Primary DI
00757770433339
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N1365
Catalog number
N1365
Device description
TB SUCT FERG-FRAZIER 9FR 150MM
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JZFTube, Ear Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00757770433339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770433339007577704333397577704333390757770433339

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
196603781
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00757770428588Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770676491Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770425044Bausch + LombBausch & Lomb IncorporatedJZF2026-02-04
00757770446629Bausch + LombBausch & Lomb IncorporatedJZF2025-12-12
09348811000743INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-12-02
00757770701230Bausch + LombBausch & Lomb IncorporatedJZF2025-11-16
00757770436842Bausch + LombBausch & Lomb IncorporatedJZF2025-11-14
04250676745668Suction tube with windowSpiggle & Theis Medizintechnik GmbHJZF2025-09-19
00757770452682Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
00757770680498Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
04250676740533Saxby-IrrigatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-11
04250676722539Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722546Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722553Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722560Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722577Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722584Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722591Panetti suction separatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722607Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722614Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676733153Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733160Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733177Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733184Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733191Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733207Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733214Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738547Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738554Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676742865Preyer dissector, sinus tympaniSpiggle & Theis Medizintechnik GmbHJZF2025-09-03