FDA.reportPublic FDA data

NMS Umbilical Cord Kit

Primary DI
00860013969530
Brand
NMS Umbilical Cord Kit
Company
Ditek Consulting, LLC
Model
380371G
Device description
NMS Umbilical Cord Kit
Published
2025-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013969530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013969530008600139695308600139695300860013969530

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111296701
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
00860013969561Specimen Collection Kit1463452025-10-13
00860011770282Kidney Stone Collection Kit1462252025-09-11
00860013969554Ditek BioBank Kit (Labcorp)1460452025-08-28
00860013969547High Altitude QuantiFERONTest Kit1217272025-06-17
10860013969544High Altitude QuantiFERONTest Kit1217272025-06-17
00860013899264Paternity Test Kit 50469332025-05-06
00860013899288Paternity Test Kit 25926962025-05-06
10860013899261Paternity Test Kit 50469332025-05-06
00860013899271Paternity Test Kit 1968352025-05-06
10860013899285Paternity Test Kit 25926962025-05-06
00860013899295Colofit Test KitDTCF012025-05-06
00860013969509Kidney Combo Test Kit 1KHK012025-05-06
00860013969516Kidney Health Test Kit 2 eGFR012025-05-06
00860013969523Kidney Health Test Kit 3uACR012025-05-06
00860011770268Covid 19 Testing Kit1413142025-05-01
00860011770220NIPS Single Pack Testing Kit1163732025-05-01
10860011770265Covid 19 Testing Kit1413142025-05-01
10860011770203Alzheimer's Evalutation CSF Kit1408572025-05-01
20860011770231NIPS Combo Collection Kit1312612025-05-01
10860009616018Adult Blood Culture Collection Kit1251842024-11-13

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