FDA.reportPublic FDA data

MedDrain

Primary DI
00850005416050
Brand
MedDrain
Company
ARMM INC.
Model
25296
Device description
MedDrain Double Sump Drain, 32 Small Eyes - 20" Long
Published
2023-06-08
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

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
10850005416057PrimaryGS10
00850005416050Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000541605710850005416057
00850005416050008500054160508500054160500850005416050

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7148488190info@armminc.com

Regulatory Flags#

DUNS number
797391778
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

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
10850005416064MedDrainARMM INC.GBN2023-06-08
10850082007971MedDrainARMM INC.GBN2023-06-08
10850082007988MedDrainARMM INC.GBN2023-06-08
00850005416029MedDrainARMM 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