FDA.reportPublic FDA data

Spirometrics

Primary DI
00855784004290
Brand
Spirometrics
Company
Spirometrics
Model
D1060
Device description
Nose Clip, each
Published
2017-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXJClip, Nose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXJClip, NoseAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855784004177PackageGS1200Not in Commercial Distribution
00855784004184PackageGS1200Not in Commercial Distribution
00855784004191PackageGS13Not in Commercial Distribution
00855784004290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855784004177008557840041778557840041770855784004177
00855784004184008557840041848557840041840855784004184
00855784004191008557840041918557840041910855784004191
00855784004290008557840042908557840042900855784004290

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
207-657-6700info@spirometrics.com

Regulatory Flags#

DUNS number
830864406
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855784004009VeinsiteVTS10002018-12-04
00855784004269Spiro-FilterD10102016-10-11
00855784004276SpirometricsD10302017-04-03
00855784004283SpirometricsD10202017-04-03
00855784004016SpiroFlowE5010E5010-22016-10-11
00855784004047SpiroFlowE5020E5020-22016-10-11
00855784004207SpirometricsN4010N4010-22017-04-03
00855784004214SpirometricsN4010N4010-2-VAC2017-04-03
00855784004245SpiroFlowE5010E5010-2-NOV2016-10-11
00855784004252SpiroFlowE5020E5020-2-NOV2016-10-11
00855784004085Spiro-FilterD10102016-10-11
00855784004160SpirometricsD10302017-04-03
00855784004146SpirometricsD10202017-04-03
00855784004030SpiroFlowE5010E5010-22016-10-11
00855784004054SpiroFlowE5020E5020-22016-10-11
00855784004191SpirometricsD10602017-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060120956415Nose ClipGVS FILTER TECHNOLOGY UK LTDBXJ2026-02-10
15060120956412Nose ClipGVS FILTER TECHNOLOGY UK LTDBXJ2026-02-10
14250892907007JaegerJaeger Medical GmbHBXJ2025-06-02
14250892907014JaegerJaeger Medical GmbHBXJ2025-06-02
14250892907021JaegerJaeger Medical GmbHBXJ2025-06-02
00816472022545Nose Clip with PaddingIntersurgical IncorporatedBXJ2025-04-14
00816472022552Nose Clip with PaddingIntersurgical IncorporatedBXJ2025-04-14
00817081028287Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonA-M SYSTEMS, LLCBXJ2025-02-25
00817081028300Disposable Blue PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028324Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028294Disposable White PFT Nose Clip with Rubber Pads, Labeled D R BurtonA-M SYSTEMS, LLCBXJ2025-02-25
00817081028317Disposable Blue PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028331Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028201PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-20
00817081028218PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-20
00840117322004Resp-O2 PFM Nose Clips, Adult / Pediatric Dynarex CorporationBXJ2024-10-21
00840117321991Resp-O2 PFM Nose Clips, Adult / Pediatric Dynarex CorporationBXJ2024-10-21
M996NC125850NC 12585 Nose ClipINSTRUMENTATION INDUSTRIES, INCORPORATEDBXJ2024-07-16
00026072012154BFAllied Medical, LLCBXJ2024-05-28
07613365500103NoseclipGanshorn Medizin Electronic GmbHBXJ2023-07-03
00810016250616Medical GraphicsMEDICAL GRAPHICS CORPORATIONBXJ2023-06-14
00817081027495Disposable PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2023-03-16
00817081027501Disposable PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2023-03-16
00810071633614CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633621CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633638CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633645CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633652CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00810071633669CuraplexBOUND TREE MEDICAL, LLCBXJ2022-12-30
00817081027396Disposable PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2022-11-15