FDA.reportPublic FDA data

Heimlich valve

Primary DI
08034139291130
Brand
Heimlich valve
Company
REDAX SPA
Model
10530
Catalog number
10530
Device description
The Heimlich non-return valve is a one-way drainage device which prevents the air reflux towards the patient's chest.
Published
2020-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18034139291137PackageGS150In Commercial Distribution
08034139291130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803413929113718034139291137
08034139291130080341392911308034139291130

GMDN Terms#

Term, Definition table
TermDefinition
Pleural drainage valveA sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+17868187337christian.costantini@redax.it

Regulatory Flags#

DUNS number
338664915
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034139292809Thoracic Catheter, Straight Fr 1220812208122021-05-04
08034139292816Thoracic Catheter, Straight Fr 1520815208152021-05-05
08034139292823Thoracic Catheter, Straight Fr 1820818208182021-05-07
08034139292830Thoracic Catheter, Straight Fr 2120821208212021-05-07
08034139292847Thoracic Catheter, Straight Fr 2420824208242021-05-07
08034139292854Thoracic Catheter, Straight Fr 2820828208282021-05-05
08034139292861Thoracic Catheter, Straight Fr 3020830208302021-05-07
08034139292878Thoracic Catheter, Straight Fr 3320833208332021-05-07
08034139292885Thoracic Catheter, Straight Fr 3620836208362021-05-05
08034139293783Thoracic Catheter, Angled Fr 2421824218242021-05-05
08034139293790Thoracic Catheter, Angled Fr 2821828218282021-05-05
08034139293806Thoracic Catheter, Angled Fr 3021830218302021-05-07
08034139293813Thoracic Catheter, Angled Fr 3321833218332021-05-07
08034139293820Thoracic Catheter, Angled Fr 3621836218362021-05-05
08034139290874Drentech Pump 100 ml Round Drainage w/trocar Fr 1510483104832021-05-04
08034139294506Flat Drain type Jackson-Pratt 3x7 mm24100241002021-05-03
08034139294513Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar24101241012021-05-05
08034139294520Flat Drain type Jackson-Pratt 3x7 mm24110241102021-05-05
08034139294537Flat Drain type Jackson-Pratt 3x7 mm w/trocar24111241112021-05-05
08034139294544Flat Drain 3/4 type Jackson-Pratt 4x10 mm24120241202021-05-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704937292PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
14026704937353PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-05-08
00628725095363Pleural Drain Dry Seal System CHS USA Inc.KDQ2026-04-17
00628725095370Pleural Drain Wet Seal System CHS USA Inc.KDQ2026-04-17
40884389968100MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
40884389968124MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
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10192253002645Thora-SealCardinal Health 200, LLCKDQ2025-02-18
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