FDA.reportPublic FDA data

All Flow

Primary DI
00384620000016
Brand
All Flow
Company
ALLIANCE TECH MEDICAL INC
Model
5553100
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043148000ALL FLOW PULMONARY FUNCTION FILTERAlliance Tech Medical, Inc.2004-12-13CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384620000016PrimaryGS10
10384620000013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384620000016003846200000163846200000160384620000016
1038462000001310384620000013

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing kitA collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144713174
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384620000733InFloCone13570502023-09-08
00384620000757All Flow Valved Insp. Mthpc31220692023-09-08
00384620000764All Flow Valved Ex.Mthpc.31220642023-09-08
00384620000771All Flow Adult Disp Mthpc.31222002023-09-08
00384620000788All Flow Peds Disp Mthpc.31232002023-09-08
00384620000795All Flow Mthpc. Adapter31222202023-09-08
00384620000801All Flow Resp. Disp. Mthpc.31255002023-09-08
00384620000818All Flow Thermoplastic Rbr Mthpc.55500502023-09-08
10384620000730InFloCone13570502023-09-08
10384620000754All Flow Valved Insp. Mthpc31220692023-09-08
10384620000761All Flow Valved Ex.Mthpc.31220642023-09-08
10384620000778All Flow Adult Disp Mthpc.31222002023-09-08
10384620000785All Flow Peds Disp Mthpc.31232002023-09-08
10384620000792All Flow Mthpc. Adapter31222202023-09-08
10384620000808All Flow Resp. Disp. Mthpc.31255002023-09-08
10384620000815All Flow Thermoplastic Rbr Mthpc.55500502023-09-08
00384620000177InFloCone-V14590502023-09-01
10384620000174InFloCone-V14590502023-09-01
00384620000054All Flow55571002019-09-11
00384620000009All Flow55511002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109509Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-07-23
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600Dynarex CorporationCAH2021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) FilterDynarex CorporationCAH2021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V FilterDynarex CorporationCAH2021-04-22
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex TubeDynarex CorporationCAH2021-04-22