FDA.reportPublic FDA data

PFM

Primary DI
55099169439004
Brand
PFM
Company
VITALOGRAPH (IRELAND) LIMITED
Model
4300
Device description
4300 PEAK FLOW METER myPEF (NON WEB)
Published
2016-12-06
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
false

Product Codes#

Code, Name table
CodeName
BXWCALIBRATOR, VOLUME, GAS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781922000PULMONARY MONITORVitalograph , Ltd.1979-02-13BZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35099169439000PackageGS125In Commercial Distribution
55099169439004PackageGS140In Commercial Distribution
05099169439009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3509916943900035099169439000
5509916943900455099169439004
05099169439009050991694390095099169439009

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, manualA manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219683489
Device count
1
DM exempt
false
Premarket exempt
false
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
00851845007248comPAS291704917042026-06-03
050991693321579100 VITALOGRAPH VitaloLAB+91510915102026-06-02
15099169203102Mouthpiece20202020-06-21
15099169283814PFT28202016-12-01
15099169283821PFT28202016-12-01
050991698301272120 In2itive - Brazil83012830122025-04-30
05099169770508Pneumotrac68002017-11-15
05099169919105VitaloROV91002024-07-31
15099169331898Mouthpiece20202024-04-08
15099169203928Mouthpiece20202018-05-15
15099169251004Aspirator25102018-05-09
65099169688003SPIROTRAC70002021-04-30
15099169202013Mouthpiece20202016-12-08
15099169202020Mouthpiece20202018-05-15
15099169202426Safe-T-Way20242016-12-08
15099169202464Safe-T-Way20242016-12-08
15099169209203Safe-T-Way20242016-12-08
15099169209227Safe-T-Way20242016-12-08
15099169209241Safe-T-Way20242016-12-08
15099169209296Safe-T-Way20242018-05-15

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