FDA.reportPublic FDA data

Single Lead Low PV Pump Chamber Set

Primary DI
10810080610634
Brand
Single Lead Low PV Pump Chamber Set
Company
MPS Pharma & Medical, Inc.
Model
G827331-M
Published
2022-08-24
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
JTBDevice, Media Dispensing/Stacking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTBDevice, Media Dispensing/StackingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810080610634PackageGS110In Commercial Distribution
00810080610637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081008061063410810080610634
00810080610637008100806106378100806106370810080610637

GMDN Terms#

Term, Definition table
TermDefinition
Compounding transfer setA collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117970217
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810080612525OptiDropper®, SafeFill™UA15-415-50-TRAY-15CR2026-05-14
00810080612532OptiDropper®, SafeFill™UA15-415-109-TRAY-5-WHT2026-05-14
00810080612549OptiDropper®UA15-415-10-BOT-52026-05-14
00810080612556OptiDropper®UA15-415-10-BOT-5-WHT2026-05-14
00810080612563SAFEFILL™UA15-415-50-TRAY-10-WHT2026-05-14
00810080612518CONNECTOR LUER FEMALE/MALEPLS616082025-11-07
00810080612501OptiDropper®, SafeFill™UA15-415-109-TRAY-52025-10-22
00810080612495OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
10810080612492OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
00810080612488OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
10810080612485OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
00810080612464OptiDropper®UA15-415-108-TRAY-72025-07-19
10810080612461OptiDropper®UA15-415-108-TRAY-72025-07-19
00810080612372OptiDropper™ AC211633-122025-05-13
10810080612379OptiDropper™ AC211633-122025-05-13
00810080612327OptiDropper™AC211631-22025-05-12
00810080612334OptiDropper™ AC211631-3002025-05-12
00810080612341OptiDropper™ AC211632-12025-05-12
00810080612358OptiDropper™AC211632-122025-05-12
00810080612365OptiDropper™AC211633-12025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810080610484Single Lead High Volume Pump ChamberMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610491SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610507TRIPLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610514DUAL LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610521SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610538SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610545SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610552SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610569DUAL LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610583SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610590SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET W/WEIGHTMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610606SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET W/WEIGHTMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610620SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610637Single Lead Low PV Pump Chamber SetMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610644DUAL LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
00810080610651TRIPLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610498SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610535SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610542SINGLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610597SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET W/WEIGHTMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610641DUAL LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24
10810080610658TRIPLE LEAD HIGH VOLUME PUMP CHAMBER SETMPS Pharma & Medical, Inc.JTB2022-08-24