FDA.reportPublic FDA data

All Flow

Primary DI
00384620000009
Brand
All Flow
Company
ALLIANCE TECH MEDICAL INC
Model
5551100
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
00384620000009PrimaryGS10
10384620000006Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384620000009003846200000093846200000090384620000009
1038462000000610384620000006

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
00384620000016All Flow55531002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
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
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21
00848530099503Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530092283Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530104511Oxygen FilterSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530104689Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105372Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105389Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
008485301044366IN HEPA Capsule with Removable StickerSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104863Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104672Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-04-21