FDA.reportPublic FDA data

Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L

Primary DI
00899054002838
Brand
Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L
Company
KDL Medical, Inc.
Model
HAF-2LGS
Device description
Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm L
Published
2025-02-10
Public version status
Update
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002838PrimaryGS10
10899054002835Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002838008990540028388990540028380899054002838
1089905400283510899054002835

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Contacts#

Phone, Email table
PhoneEmail
972-783-7005regulatory@chasemedical.com

Regulatory Flags#

DUNS number
791048924
Device count
5
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002005Sof-Flo Atraumatic Coronary Artery ShuntSHT-1210S2017-03-09
00899054002012Sof-Flo Atraumatic Coronary Artery ShuntSHT-1215S2017-03-14
00899054002029Bulb Tip Coronary Artery ShuntsSHB-1215S2017-03-09
00899054002036Bulb Tip Coronary Artery ShuntsSHB-3030S2017-03-14
00899054002043Bulb Tip Coronary Artery ShuntsSHB-3025S2017-03-14
00899054002050Bulb Tip Coronary Artery ShuntsSHB-3040S2017-03-14
00899054002074Sof-Flo Atraumatic Coronary Artery ShuntSHT-1213S2017-03-14
00899054002081Sof-Flo Atraumatic Coronary Artery ShuntSHT-1218S2017-03-14
00899054002104Sof-Flo Atraumatic Coronary Artery ShuntSHT-1220S2017-03-14
00899054002128Sof-Flo Atraumatic Coronary Artery ShuntSHT-1225S2017-03-14
00899054002135Bulb Tip Coronary Artery ShuntsSHB-1218S2017-03-14
00899054002159Bulb Tip Coronary Artery ShuntsSHB-1220S2017-03-14
00899054002173Bulb Tip Coronary Artery ShuntsSHB-1225S2017-03-14
00899054002180Bulb Tip Coronary Artery ShuntsSHB-1230S2017-03-14
00899054002265Viper II Apical LiftAPI-700VS2017-08-23
00899054002272Viper II Blower MisterBLM-700MS2017-08-23
00899054002296Foot Pedal, Dual ValveFTV-10202017-08-24
00899054002302FasTract Sternal RetractorRTC-10002017-08-24
00899054002319FasTract Sternal Retractor, Deep BladesRTC-1000-C012017-08-24
00899054002401FasTract Modified Sternal Retractor, Deep BladesRTC-1000-C022017-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437060MillenniumAvalign Technologies, Inc.DWS2026-10-26
00190776436995MillenniumAvalign Technologies, Inc.DWS2026-10-23
04058749009118NAFehling Instruments GmbH & Co. KGDWS2026-10-23
04058749010299NAFehling Instruments GmbH & Co. KGDWS2026-10-23
04058749115321NAFehling Instruments GmbH & Co. KGDWS2026-10-23
00724995279974V. MuellerSTERIS Deutschland GmbHDWS2026-10-21
00190776436674MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776436704MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437657MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437770MillenniumAvalign Technologies, Inc.DWS2026-10-20
00190776437794MillenniumAvalign Technologies, Inc.DWS2026-10-20
03661219455073LANDANGERLANDANGERDWS2026-10-19
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12