Who else makes this device?

Name: Sapphire Epidural Infusion Kit-US
Brand: Sapphire Epidural Infusion Kit-US

General Hospital › TherapeuticPump, Infusion

Sapphire Epidural Infusion Kit-US

2 catalogue numbers from 17000-031-0027, listed by Eitan Medical Ltd, Israel, under Pump, Infusion. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FRN
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
JDI Electronics Factory	Dongguan	Guangdong	Contract manufacturer	7
Zyno Electric & Machinery Ltd, Shanghai	Shanghai	Shanghai	Contract manufacturer	1
Sterigenics Shanghai E Beam Ltd.	Shanghai	Shanghai	Contract manufacturer	14

Record

Regulatory record for Sapphire Epidural Infusion Kit-US
Listed by	Eitan Medical Ltd, Israel
FDA product code	FRN
Device type	Pump, Infusion
Device class	Class 2
Regulation	21 CFR 880.5725
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K123049
Record published	2016-09-01
Record revised	2022-11-23 (version 6)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -40 to 70 °C
Packaging	Cardboard box of 8, pack of 16

Catalogue Numbers

Catalogue numbers for Sapphire Epidural Infusion Kit-US
Catalogue number	Size	Status
17000-031-0027		In distribution
17000-031-1040		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Port Access Infusion SET	Sb-Kawasumi Laboratories, Inc.	76
Cadd	ICU Medical, Inc	56
Flow Control Tubing	GO Medical Industries PTY. Ltd.	39
Curlin Administration Set	Zevex, Inc.	30
ambIT	Summit Medical Products, Inc.	27
Beeline motIV	Rex Pj Tech LLC	24
RMS Precision Flow Rate TubingTM	Repro-Med Systems, Inc.	24
Medfusion	ICU Medical, Inc	24
Volumat™ Line	Fresenius Kabi AB	24
Outlook®	B. Braun Medical Inc.	21
Alaris	CareFusion 303, Inc	19
Alpha Source Battery	Alpha Source Inc.	17

Showing 12 of 191. All products under Pump, Infusion

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213744	2023-03-10

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Sapphire Epidural Infusion Kit-US
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Eitan Medical Ltd	510(k) number	2023-09-11	Class I	Software Design Change	Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.	1383

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.