FDA.reportPublic FDA data

Beeline motIV

Primary DI
10857362007133
Brand
Beeline motIV
Company
Rex Pj Tech LLC
Model
BL1D100
Device description
Infusion Set (100.0 ml/hr)
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857362007133PackageGS110In Commercial Distribution
00857362007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085736200713310857362007133
00857362007136008573620071368573620071360857362007136

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical infusion pump kit, medicatedA collection of sterile devices intended to be used in a clinical setting for continuous localized infusion of a single dose of analgesic medication (e.g., ropivacaine), using a non-electric/non-elastic mechanical infusion pump, for regional anaesthesia and postoperative pain management. It consists of a mechanical infusion pump prefilled with medication, and additional medication administration devices (e.g., infusion catheter). The infusion catheter is intended to be inserted during surgery and connected to the tubing line of the prefilled infusion pump for infusion of the drug into the operative site. The device can be worn by the patient during ambulation. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
096931706
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857362007020Beeline motIVBL1D00/62021-01-04
00857362007037Beeline motIVBL1D00/82021-01-04
00857362007044Beeline motIVBL1D01/52021-01-04
00857362007051Beeline motIVBL1D0022021-01-04
00857362007068Beeline motIVBL1D0042021-01-04
00857362007075Beeline motIVBL1D0052021-01-04
00857362007082Beeline motIVBL1D0082021-01-04
00857362007112Beeline motIVBL1D0102021-01-04
00857362007129Beeline motIVBL1D0502021-01-04
00857362007136Beeline motIVBL1D1002021-01-04
00857362007143Beeline motIVBL1D2002021-01-04
00857362007150Beeline motIVBL1D2502021-01-04
00857362007228Beeline motIVSK22021-01-04
00857362007235Beeline motIVYK22021-01-04
00857362007242Beeline motIVSK52021-01-04
00857362007259Beeline motIVYK52021-01-04
00857362007266Beeline motIVSK62021-01-04
00857362007273Beeline motIVYK62021-01-04
00857362007280Beeline motIVSK82021-01-04
00857362007297Beeline motIVYK82021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18