FDA.reportPublic FDA data

NOSE CLIP

Primary DI
03760253450270
Brand
NOSE CLIP
Company
FIM MEDICAL
Model
NOSE CLIP
Published
2017-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161676000Q13 SPIROLYSER®Fim Medical2016-10-20BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760253450270PrimaryGS10
03760253450201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760253450270037602534502703760253450270
03760253450201037602534502013760253450201

GMDN Terms#

Term, Definition table
TermDefinition
Nose clip, single-useA device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(619)272-1323olivier.derei@depisteo.com
+33(0)672559096joanna.corre@depisteo.com

Regulatory Flags#

DUNS number
577219207
Device count
200
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760253450638ErgofilterSP12023-09-04
03760253450645ErgofilterSP1M2023-09-04
03760253450614SPIROWINExpert2023-07-05
03760253450621SPIROWIN EXPERT DEPISTEO2023-07-05
03760253450263PipettePipette2017-09-15
03760253450577VT1Software 2022-06-07
03760253450157VT1Software2017-10-17
03760253450249VT1ESSENTIAL EDITION2017-10-16
03760253450607SPIROWIN EXPERT DEPISTEO2022-03-16
03760253450010Spirowin Expert2017-05-04
03760253450447VT1 Junior SHVT1 Junior SH FF10852021-11-30
03760253450454VT1 US FAAVT1 FAA FF10842021-11-30
03760253450461Face cover for Visiolite/VT1FF10862021-11-30
03760253450522Q13 DEPISTEO SpirolyserFF1153 Q13 Depisteo2021-11-30
03760253450546VT1 DMV-BDMV-B2021-11-30
03760253450553VT1 DMV-CDMV-C2021-11-30
03760253450560VT1 DMV-DDMV-D2021-11-30
03760253450195QFLOWQFLOW2017-05-04
03760253450003SpirolyserQ132017-05-04
03760253450287TRAPPERTRAPPER2017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
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08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320363MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320431MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320462MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320509MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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08052990320547MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320554MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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