FDA.reportPublic FDA data

Spirometrics

Primary DI
00855784004207
Brand
Spirometrics
Company
Spirometrics
Model
N4010
Catalog number
N4010-2
Device description
3 Liter Calibration Syringe, Spirometrics label
Published
2017-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXWCalibrator, Volume, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXWCalibrator, Volume, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855784004207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855784004207008557840042078557840042070855784004207

GMDN Terms#

Term, Definition table
TermDefinition
Gas volume reference standardA manual instrument intended to deliver a precise, known quantity of gas (e.g., 1 litre) for the purposes of calibrating/testing a medical device partially or completely dedicated to measuring/monitoring volumes of air/gas (e.g., anaesthesia monitor, diagnostic spirometer). It is typically presented as a syringe-like device with a manually-operated plunger and may include appropriate connecting tubing. This device is intended to be used by a healthcare provider in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830864406
Device count
1
Premarket exempt
true
Serial number
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
00855784004290SpirometricsD10602017-04-03
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
008171360277395530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
008171360277465530 3L SYRINGEHANS RUDOLPH, INC.BXW2026-05-01
34250892907407JaegerJaeger Medical GmbHBXW2025-07-24
34250892907421JaegerJaeger Medical GmbHBXW2025-07-24
04250892907413JaegerJaeger Medical GmbHBXW2025-07-23
04250892907888JaegerJaeger Medical GmbHBXW2025-07-23
008170810279143 Liter Aluminum Calibration Syringe w/ AdapterA-M SYSTEMS, LLCBXW2024-11-07
008171360276855530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-07-02
008171360276785530 3L SYRINGEHANS RUDOLPH, INC.BXW2024-02-13
008171360276615570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-11-08
008171360276545570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-21
008171360276475570 3L SYRINGEHANS RUDOLPH, INC.BXW2023-08-17
008571750060673L Calibration SyringeVECTRACOR INCBXW2023-06-07
00817081027594Syringe, Calibration, Adj. Vol., AluminumA-M SYSTEMS, LLCBXW2023-05-17
008171360270435540 1L SYRINGEHANS RUDOLPH, INC.BXW2023-01-05
008171360270365570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-12-16
008171360269095530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360269165530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-08-08
008171360268795530 3L SYRINGEHANS RUDOLPH, INC.BXW2022-05-16
008171360268005570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-03-08
04250892906645VyaireJaeger Medical GmbHBXW2021-11-15
008170810271053 Liter Aluminum Calibration SyringeA-M SYSTEMS, LLCBXW2021-10-06
008171360267495530 3L SYRINGEHANS RUDOLPH, INC.BXW2021-09-23
00817081027051SYRINGE, CALIBRATION, ADJ. VOL., ALUMINUM,A-M SYSTEMS, LLCBXW2021-09-09
008171360267185570 3L SYRINGEHANS RUDOLPH, INC.BXW2021-08-06
04250892906102VyaireJaeger Medical GmbHBXW2021-07-16
04250892906140VyaireJaeger Medical GmbHBXW2021-07-16
34250892906110VyaireJaeger Medical GmbHBXW2021-07-16
34250892906127VyaireJaeger Medical GmbHBXW2021-07-16
34250892906134VyaireJaeger Medical GmbHBXW2021-07-16