FDA.reportPublic FDA data

Pro Response Kit

Primary DI
00850070635370
Brand
Pro Response Kit
Company
Nar Medical Depot, LLC
Model
800-00118
Catalog number
800-00118
Device description
GYNECOLOGICAL EXAMINATION KIT
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MLTPelvic Exam Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLTPelvic Exam KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070635370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070635370008500706353708500706353700850070635370

Regulatory Flags#

DUNS number
117667182
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00850070635349Pro Response Plus Kit800-00126800-001262026-11-05
00850070635363Pro Response Plus Kit800-00130800-001302026-11-05
00850070635226Response Kit800-00064800-000642026-10-23
00850070635240Pro Response Kit800-00067800-000672026-10-23
00850070635257Response Kit800-00070800-000702026-10-23
00850070635264Pro Response Kit800-00071800-000712026-10-23
00850070635271Response Plus kit800-00105800-001052026-10-23
00850070635288Response Kit800-00120800-001202026-10-23
00850070635295Response Plus kit800-00121800-001212026-10-23
00850070635301Pro Response Kit800-00122800-001222026-10-23
00850070635318Pro Response Kit800-00123800-001232026-10-23
00850070635332Response Kit800-00125800-001252026-10-23
00850070635356RESPONSE KIT800-00119800-001192026-10-23
00850070635172FIRST AID REFILL KIT800-00111800-001112026-07-24
00850070635189FIRST AID KIT CABINET800-00112800-001122026-07-24
00850070635196FIRST AID KIT800-00113800-001132026-07-24
00850070635202TRAUMA RESPONSE KIT800-00039800-000392026-07-24
00850070635165KIT, FIRST AID800-00114800-001142026-06-25
00850070635158KIT, BLOOD CULTURE COLLECTING800-00087800-000872026-03-19
00850070635141KIT, FIRST AID800-00100800-001002026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956037649CARDINAL HEALTHCardinal Health 200, LLCMLT2025-05-21
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