FDA.reportPublic FDA data

MedDrain

Primary DI
10850005416064
Brand
MedDrain
Company
ARMM INC.
Model
25289C
Device description
"MedDrain 6.5mm Mediastinal Filtered Drain - Mono Sump - 6 Large Eyes, 18"" Long, Coated"
Published
2023-06-08
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
GBNCatheter, Pediatric, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBNCatheter, Pediatric, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931607000MEDDRAINSArmm, Inc.1993-08-06GBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005416064PrimaryGS10
00850005416067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000541606410850005416064
00850005416067008500054160678500054160670850005416067

GMDN Terms#

Term, Definition table
TermDefinition
Sump drainA sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7148488190info@armminc.com

Regulatory Flags#

DUNS number
797391778
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850082007384MedDrain232142017-02-22
10850082007391MedDrain232162017-02-22
10850082007407MedDrain232202017-02-22
10850082007414MedDrain232242017-02-22
10850082007421MedDrain232282017-02-22
10850082007438MedDrain232322017-02-22
10850082007445MedDrain232362017-02-22
10850082007452MedDrain232402017-02-22
10850082007469MedDrain23214C2017-02-22
10850082007476MedDrain23216C2017-02-22
10850082007483MedDrain23220C2017-02-22
10850082007490MedDrain23224C2017-02-22
10850082007506MedDrain23228C2017-02-22
10850082007513MedDrain23232C2017-02-22
10850082007520MedDrain23236C2017-02-22
10850082007537MedDrain23240C2017-02-22
10850082007544MedDrain2320162017-02-23
10850082007551MedDrain2320202017-02-23
10850082007568MedDrain2320242017-02-23
10850082007575MedDrain2320282017-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850005416026MedDrainARMM INC.GBN2023-06-08
10850005416057MedDrainARMM INC.GBN2023-06-08
10850082007971MedDrainARMM INC.GBN2023-06-08
10850082007988MedDrainARMM INC.GBN2023-06-08
00850005416029MedDrainARMM INC.GBN2023-06-08
00850005416050MedDrainARMM INC.GBN2023-06-08
00850005416067MedDrainARMM INC.GBN2023-06-08
00850082007974MedDrainARMM INC.GBN2023-06-08
00850082007981MedDrainARMM INC.GBN2023-06-08
00817213021537NATIONAL HOSPITAL PACKAGINGSurgi-Pak, Inc.GBN2022-12-06
EAMICDS20100Comfort Drain GrasperAMI Agency for Medical Innovations GmbHGBN2018-11-29
EAMICDS20010Comfort Drain AMI Agency for Medical Innovations GmbHGBN2018-11-28
10850082007865MedDrainARMM INC.GBN2018-11-02
10850082007872MedDrainARMM INC.GBN2018-11-02
10850082007933MedDrainARMM INC.GBN2018-11-02
10850082007940MedDrainARMM INC.GBN2018-11-02
10850082007957MedDrainARMM INC.GBN2018-11-02