FDA.reportPublic FDA data

Heavy Aspiraton Tubing

Primary DI
30816989020004
Brand
Heavy Aspiraton Tubing
Company
HK SURGICAL INC.
Model
AT375
Catalog number
AT375
Device description
ASPIRATION TUBING SET
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38169890200006PreviousGS10
30816989020004PrimaryGS10
10816989020000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3816989020000638169890200006
3081698902000430816989020004
1081698902000010816989020000

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
949-369-0101hkinfo@hksurgical.com

Regulatory Flags#

DUNS number
106885259
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816989021468HK Klein Infiltration Pump+KIP-II+KIP-II+2025-09-29
00816989020874"HK Tumescent Infiltration Cannula, (15cm) 6""-12 gauge, Single Use, Box of 10"SU-IC12x15SU-IC12x152020-11-20
00816989021437HK Klein TDD PumpKTDDKTDD2024-08-29
00816989021130HK Mercedes Cannula 3mm X 15cm Luer LockHKMER315HKMER3152023-12-21
00816989021147HK Mercedes Cannula 2mm X 15cm Luer LockHKMER215HKMER2152023-12-21
00816989021154HK Mercedes Cannula 3mm X 25cm Luer LockHKMER325HKMER3252023-12-21
00816989021161"HK Mercedes Cannula 3mm X 30cm (12"") Luer Lock"HKMER330HKMER3302023-12-21
00816989021178HK Mercedes Cannula 4mm X 25cm Luer LockHKMER425HKMER4252023-12-21
00816989021185"HK Mercedes Cannula 4mm X 30cm (12"") Luer Lock"HKMER430HKMER4302023-12-21
00816989021192HK HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock)HKMER+215HKMER+2152023-12-21
00816989021208HK Mercedes Plus Cannula 3mm X 25cm Luer LockHKMER+325HKMER+3252023-12-21
00816989021215HK Mercedes Plus Cannula 4mm X 25cm Luer LockHKMER+425HKMER+4252023-12-21
00816989021222HK Tri-port Cannula 3mm x 25cm Luer LockHKTRI325HKTRI3252023-12-21
00816989021239HK Tri-port plus Cannula 2mm x 15cm Luer LockHKTRI+215HKTRI+2152023-12-21
00816989021246HK Tri-port plus Cannula 3mm x 25cm Luer LockHKTRI+325HKTRI+3252023-12-21
00816989021253HK Tri-port plus Cannula 4mm x 25cm Luer LockHKTRI+425HKTRI+4252023-12-21
00816989021260HK Spatula Single Hole Cannula 12ga x 15cm Luer LockHKSPA1215HKSPA12152023-12-21
00816989021277HK Spatula Single Hole Cannula 14ga x 15cm Luer LockHKSPA1415HKSPA14152023-12-21
00816989021284"HK Spatula Single Hole Cannula 3mm X 15cm (6"") Luer Lock"HKSPA315HKSPA3152023-12-21
00816989021291HK TOL Toledo Cannula 2mm x 15cm Luer LockHKTOL215HKTOL2152023-12-21

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