FDA.report

NAMIC

Primary DI
10193489066906
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
80097107
Catalog number
80097107
Device description
SYRINGE 12ML PP/FG RA - OEM - PG
Published
2021-05-12
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

Related Records

Product Codes

CodeName
DXTInjector and syringe, angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions

SubmissionSupplement
K873955000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K873955000NAMIC ANGIOGRAPHIC SYRINGENorth American Instrument Corp.1988-02-05DXT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489066903PrimaryGS10
10193489066906Unit of UseGS10

GMDN Terms

TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
50
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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