FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160429778
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
83945
Published
2024-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFTSpinal epidural anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160429775PackageGS120Not in Commercial Distribution
10809160429778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916042977520809160429775
1080916042977810809160429778

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07
10809160520468Medical Action Industries771202026-05-05
10809160016770Medical Action Industries718912016-08-20
10809160394052Medical Action Industries833482023-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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