Medline Pressure Infuser Bag 1000ml

GUDID 10816317024274

RENU MEDICAL, INC

Intravenous pressure infusor, manual, single-use
Primary Device ID10816317024274
NIH Device Record Keye35e3a12-70ca-43a2-8423-430af7c4183a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedline Pressure Infuser Bag 1000ml
Version Model NumberRM-DYNJAAPI1000B
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816317024277 [Primary]
GS110816317024274 [Package]
Contains: 00816317024277
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

KZDInfusor, Pressure, For I.V. Bags

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-10
Device Publish Date2024-12-02

Devices Manufactured by RENU MEDICAL, INC

00816317024291 - Kendall ECG Leads2025-05-09 Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in
10816317024304 - Kendall ECG Leads2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 36in
00816317024314 - Kendall ECG Leads2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 72in
10816317024328 - Kendall ECG Leads2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 72in
10816317024335 - Kendall ECG Leads2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 36in
10816317024342 - Kendall ECG Leads2025-05-09 Covidien Kendall - DUAL CONNECT LEADSET 3 LEAD 10 pin 36in
10816317024359 - Kendall ECG Leads2025-05-09 Covidien Kendall - DISPOSIBLE PH V TELEMETRY 5 LEAD 10 Pin 39in
10816317024366 - Kendall ECG Leads2025-05-09 Cardinal Health - Kendall, DUAL CONNECT SYSTEM, 6-LEAD 12 Pin 144in

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.