FDA.report

Precision Syringe

Primary DI
05099169360235
Brand
Precision Syringe
Company
VITALOGRAPH (IRELAND) LIMITED
Model
2040
Device description
2040 PRECISION SYRINGE 3 LITRE CHINESE
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
BXWCALIBRATOR, VOLUME, GAS

Product Code Classifications

CodeDeviceSpecialtyClass
BXWCalibrator, Volume, GasAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05099169360235PackageGS11In Commercial Distribution
15099169360232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05099169360235050991693602355099169360235
1509916936023215099169360232

GMDN Terms

TermDefinition
Spirometer/pulmonary function analyser syringeA dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or plastic cylinder (barrel) and steel plunger (piston) with a finely graduated scale along the length of the cylinder. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
219683489
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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