FDA.report

MEDLINE

Primary DI
00653160386691
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDV2697
Catalog number
DYNDV2697
Device description
IV START KIT
Published
2025-03-10
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

Related Records

Contact Domains

Product Codes

CodeName
LRSI.V. start kit

Product Code Classifications

CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160386691PackageGS1100In Commercial Distribution
10653160386698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160386691006531603866916531603866910653160386691
1065316038669810653160386698

GMDN Terms

TermDefinition
X-linked hydrocephalus IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder X-linked hydrocephalus or congenital hydrocephalus due to stenosis of the aqueduct of Sylvius, and associated with mutation in the gene encoding the L1 cell adhesion molecule (L1CAM), using a nucleic acid technique (NAT).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

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