FDA.report

Snorkel (N275)

Primary DI
00812594010385
Brand
Snorkel (N275)
Company
NEOTECH PRODUCTS, INC.
Model
00812594010385
Catalog number
N275
Published
2017-02-22
Public version status
Update
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
JOLCatheter And Tip, Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812594010385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812594010385008125940103858125940103850812594010385

GMDN Terms

TermDefinition
General-purpose suction system, line-poweredAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.

Sterilization Methods

Method

Regulatory Flags

DUNS number
198013435
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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