FDA.report

Medical Action Industries

Primary DI
20809160350802
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
81922
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PEVDialysis administration kit

Product Code Classifications

CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160350802PackageGS120In Commercial Distribution
10809160350805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916035080220809160350802
1080916035080510809160350805

GMDN Terms

TermDefinition
Haemodialysis start/stop setA collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
20809160517113MEDICAL ACTION INDUSTRIES843992026-03-23
20809160516574Medical Action Industries82274B2026-03-19
20809160016463Medical Action Industries716912016-08-20
20809160515195Clear Sequence836992026-03-06
20809160515218MEDICAL ACTION INDUSTRIES848602026-03-06
20809160515157MEDICAL ACTION INDUSTRIES847242026-03-05
20809160514938Medical Action Industries81329E2026-03-04
20809160514990Medical Action Industries76567F2026-03-04
20809160515003Medical Action Industries78304B2026-03-04
20809160515027Medical Action Industries77156B2026-03-04
20809160514754MEDICAL ACTION INDUSTRIES82438B2026-03-03
20809160514761MEDICAL ACTION INDUSTRIES82436B2026-03-03
20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
20809160513924MEDICAL ACTION INDUSTRIES848192026-02-25
20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

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