FDA.reportPublic FDA data

Spirometrics

Primary DI
00855784004191
Brand
Spirometrics
Company
Spirometrics
Model
D1060
Device description
Nose Clip, each
Published
2017-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00855784004177PackageGS1200In Commercial Distribution
00855784004184PackageGS1200In Commercial Distribution
00855784004191PackageGS13In 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
207-657-6700info@spirometrics.com

Regulatory Flags#

DUNS number
830864406
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
false

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
00855784004290SpirometricsD10602017-04-03
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

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