A-TAP

Primary DI
17290102590213
Brand
A-TAP
Company
Elecam Medical Agricultural Cooperative Society Ltd.
Model
NA
Catalog number
570313
Device description
A-TAP BLS RAD
Published
2024-01-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231900000A-TAP (previously called Arthrotap)Elcam Medical Acal2023-07-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290102590213PackageGS160In Commercial Distribution
27290102590210PackageGS1420In Commercial Distribution
07290102590216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010259021317290102590213
2729010259021027290102590210
07290102590216072901025902167290102590216

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure200KiloPascal

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246988120sales@elcam.co.il

Regulatory Flags#

DUNS number
532599255
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290102590216A-TAPNA5703132024-01-29
07290102590018MRVLSNA5728082016-09-24
07290102590025STP 4WAY RADNA5724882016-09-24
07290102590032STP 1 WAY RADNA5721102016-09-24
07290102590049STP LB GXL BLS RAD Large Bore Stopcock4560612020-06-01
07290102590056CSTP LB1V GXL BLS RADLarge Bore Closed stopcock4560662020-06-01
07290102590063CSTP LB 2V GXL BLSLarge Bore Closed Stopcock4560632020-06-01
07290102590070MRVLS LB1V GXL BLS RADLarge Bore MRVLS Stopcock4560642020-06-01
07290102590087MRVLS LB 2V GXL BLSLarge Bore MRVLS Stopcock4560652020-06-01
17290102590015MRVLSNA5728082016-09-24
27290102590029STP 4WAY RADNA5724882016-09-24
27290102590036STP 1 WAY RADNA5721102016-09-24

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