FDA.report

MEDLINE

Primary DI
20193489193449
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDH1351A
Catalog number
DYNDH1351A
Device description
LUMBAR PUNCTURE - CHLORAPREP
Published
2020-04-16
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
PWYLumbar puncture tray (adult & pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
PWYLumbar Puncture Tray (Adult & Pediatric)General Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489193449PackageGS16In Commercial Distribution
10193489193442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348919344920193489193449
1019348919344210193489193442

GMDN Terms

TermDefinition
Lumbar puncture kitA collection of sterile devices designed to perform a puncture of the lumbar spine to obtain spinal fluid. Typical components include a spinal needle and collection tubes for spinal fluid. This is a single-use device.

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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