FDA.reportPublic FDA data

Vyaire

Primary DI
04250892903958
Brand
Vyaire
Company
Vyaire Medical GmbH
Model
706596
Catalog number
706596
Device description
Calibration Syringe 3 Liter
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04250892903958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250892903958042508929039584250892903958

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
+499314972127support.rt.eu@vyaire.com

Regulatory Flags#

DUNS number
329769991
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
14250892906833Vyaire36-NPROBE0136-NPROBE012025-01-07
14250892906840Vyaire36-NPROBE0236-NPROBE022025-01-07
14250892906857Vyaire36-NPROBE0336-NPROBE032025-01-07
14250892906864Vyaire36-NPROBE0436-NPROBE042025-01-07
04250892905945Vyaire3.30V-7709682024-03-25
04250892905211MasterScreenV-175422V-1754222021-04-09
04250892905228MasterScreenV-175428V-1754282021-04-09
14250892906543Vyaire36-MLD162136-MLD16212021-11-16
14250892906550Vyaire36-TDX104336-TDX10432021-11-16
04250892906645Vyaire7203207203202021-11-15
14250892906499Vyaire7072387072382021-11-15
14250892906529Vyaire7072257072252021-11-15
14250892906536Vyaire7072307072302021-11-15
14250892906567Vyaire36-TDX105136-TDX10512021-11-15
14250892906574Vyaire36-TDX104836-TDX10482021-11-15
14250892906635Vyaire36-TDX105036-TDX10502021-11-15
14250892906659Vyaire7110077110072021-11-15
14250892906680Vyaire36-MFA105036-MFA10502021-09-24
14250892906697Vyaire36-MFA101036-MFA10102021-09-24
14250892906703Vyaire36-ASS127036-ASS12702021-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
04250892906645VyaireVyaire 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
04250892906102VyaireVyaire Medical GmbHBXW2021-07-16
04250892906140VyaireVyaire Medical GmbHBXW2021-07-16
34250892906110VyaireVyaire Medical GmbHBXW2021-07-16
34250892906127VyaireVyaire Medical GmbHBXW2021-07-16
34250892906134VyaireVyaire Medical GmbHBXW2021-07-16
34250892906158VyaireVyaire Medical GmbHBXW2021-07-16
34250892906462VyaireVyaire Medical GmbHBXW2021-07-16
34250892906479VyaireVyaire Medical GmbHBXW2021-07-16
34250892906486VyaireVyaire Medical GmbHBXW2021-07-16