Biotrans™ Pressure Monitoring Kits

134 catalogue numbers from 070522RD01 (BNS)-CARDIOMED, listed by Bioptimal International Pte. Ltd., Singapore, under Transducer, Blood-Pressure, Extravascular. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
134catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Zhejiang (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRS
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Unimed Medical Supplies Inc Shenzhen Guangdong Contract manufacturer 15
Shenzhen Antmed Co., Ltd. Dongguan Guangdong Manufacturer 4

Record

Regulatory record for Biotrans™ Pressure Monitoring Kits
Listed by Bioptimal International Pte. Ltd., Singapore
FDA product code DRS
Device type Transducer, Blood-Pressure, Extravascular
Device class Class 2
Regulation 21 CFR 870.2850
Establishment Manufacturer
Record published 2016-09-01
Record revised 2020-12-01 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Store in dark cool dry places
Packaging Carton of 9, box of 5, box of 10, box of 25, carton of 18, box of 20
Distribution end date 2020-12-01

Catalogue Numbers

Catalogue numbers for Biotrans™ Pressure Monitoring Kits
Catalogue number Size Status
070522RD01 (BNS)-CARDIOMED In distribution
BTR3-4812-3-BP2-S (USA) In distribution
BTR 6012-3 DL (USA) In distribution
BTR-30 (N/S & BULK PACK)-CARDIOMED In distribution
PT24 In distribution
BTR1 (USA) In distribution
BTR2-6012-3 (USA) In distribution
MV2-T SITE ADD ON KIT (USA) In distribution
BTR40 MV2-N SYRINGE KIT(USA) In distribution
91062 SINGLE LINE KIT – CHILDREN’S MERCY In distribution
PT12 In distribution
SBC-3 CANNULA LL WITH 3CC SYRINGE (USA) In distribution
CCF-STD SGL LINE MEAN SET-CC91021 In distribution
MV-1 In distribution
BP3 LS2-S Add-on Kit (USA) In distribution
MV3-N ADD ON KIT In distribution
BTR3-6012-3 (USA) In distribution
BTR-40-LS3-S (USA) In distribution
PT24 (BNS-W/O LABEL)-USA In distribution
LS2 – T SITE ADD-ON KIT In distribution
MED-LOC LOCKING CANNULA-USA In distribution
CCF-ICU TRIFURCATED KIT-CC91037 In distribution
MED-LOC LOCKING CANNULA-USA In distribution
DEADENDER PKG/4 WITH CAP (BNS) In distribution
PT06 (BNS-W/O LABEL)-USA In distribution
CCF-QUAD CUSTOM SET-CC91015 In distribution
BTR-1 W/O IFU (BNS) In distribution
BP3-LS3-S ADD-ON KIT(USA) In distribution
CCF-LEFT HEART SET-CC91010 In distribution
BP3 LS3-MV (USA) In distribution
BTR40 MV3-N In distribution
PT24(BNS)-USA In distribution
BTR-3 W/O IFU-BULK PACK (NON-STERILE) In distribution
CCF-SWAN SET-CC91011 In distribution
CCF-ICU ADD-ON KIT-CC91038 In distribution
BTR BIOTRANS DOME W/O FLUSH DEVICE(USA) In distribution
BTR40 LS2-MV In distribution
BTR 24-40(USA) In distribution
CCF-MEAN SET-CC91016 In distribution
BTR2-6012-MV (VA SLC) In distribution
DEADENDER PKG/4 WITH CAP (BNS) In distribution
BTR GREEN- CCF In distribution
COVERED NEEDLELESS CANNULA (USA) In distribution
CCF ADD ON KIT -CC91092 In distribution
PT-72 In distribution
BTR4812-3 In distribution
BTR-3-91077 McALLEN CV KIT In distribution
CCF MV ADD-ON CLOSED BLOOD DRAW SET -USA In distribution
PT06 In distribution
PT-48 In distribution
BTR-3(USA) In distribution
BTR 6012-3(USA) In distribution
BTR40 LS3-MV (USA) In distribution
EXTENSION TUBING SET In distribution
BTR-3 (BNS)-CARDIOMED In distribution
PT-36 In distribution
3-WAY STOPCOCK WHITE PKG In distribution
BTR40 LS2-S (USA) In distribution
CCF-TRIFURCATED SGL LINE SET-CC91014 In distribution
BTR W/O IFU-BULK PACK(NON-STERILE) In distribution
BTR60-40DL KIT (USA) In distribution
91065 NICU KIT – CHILDREN’S MERCY HOSPI In distribution
NORFOLK CHILDRENS ARTERIAL LINE SET In distribution
SHEATHED SYRINGE ADD-ON KIT (VA SLC) In distribution
91063 DUAL PRESSURE KIT – CHILDREN’S MER In distribution
BTR40 MV3-N Syringe Kit In distribution
PT06M (BNS-W/O LABEL)-USA In distribution
LS2 ADD-ON KIT-USA In distribution
LS2-MV (USA) In distribution
BTR-4812-3 (CAT#5510219)-GE In distribution
BTR-2448-3-BP2 (USA) In distribution
BTR-6012-MV (VA SLC) In distribution
EXTENSION TUBING SET (CCF) In distribution
PT-60 In distribution
PT12 (BNS-W/O LABEL)-USA In distribution
CCF-SINGLE LINE ADD-ON SET-CC91013 In distribution
PT72M (BNS-W/O LABEL)-USA In distribution
CCF-CARDIO ICU TRI-FUR KIT CC91039 In distribution
CHKD TRIPLE KIT-USA In distribution
91065 NICU KIT – CHILDREN’S MERCY HOSPI Withdrawn
BTR-2448-3-BP2 (USA) Withdrawn
91062 SINGLE LINE KIT – CHILDREN’S MERCY Withdrawn
91063 DUAL PRESSURE KIT – CHILDREN’S MER Withdrawn
CHKD TRIPLE KIT-USA Withdrawn
PT12 (BNS-W/O LABEL)-USA Withdrawn
BTR-3 (BNS)-CARDIOMED Withdrawn
PT12 Withdrawn
BTR-40-LS3-S (USA) Withdrawn
LS2-MV (USA) Withdrawn
PT06 Withdrawn
MV-1 Withdrawn
PT24 Withdrawn
PT06 (BNS-W/O LABEL)-USA Withdrawn
SBC-3 CANNULA LL WITH 3CC SYRINGE (USA) Withdrawn
LS2 ADD-ON KIT-USA Withdrawn
SHEATHED SYRINGE ADD-ON KIT (VA SLC) Withdrawn
BP3-LS3-S ADD-ON KIT(USA) Withdrawn
BTR-3-91077 McALLEN CV KIT Withdrawn
BTR-1 W/O IFU (BNS) Withdrawn
BTR3-4812-3-BP2-S (USA) Withdrawn
BTR40 LS2-MV Withdrawn
BTR BIOTRANS DOME W/O FLUSH DEVICE(USA) Withdrawn
BTR 6012-3(USA) Withdrawn
BTR40 MV2-N SYRINGE KIT(USA) Withdrawn
BP3 LS2-S Add-on Kit (USA) Withdrawn
BTR3-6012-3 (USA) Withdrawn
BTR40 MV3-N Withdrawn
BTR40 MV3-N Syringe Kit Withdrawn
PT-48 Withdrawn
BTR-3 W/O IFU-BULK PACK (NON-STERILE) Withdrawn
NORFOLK CHILDRENS ARTERIAL LINE SET Withdrawn
PT72M (BNS-W/O LABEL)-USA Withdrawn
BTR W/O IFU-BULK PACK(NON-STERILE) Withdrawn
BTR1 (USA) Withdrawn
PT06M (BNS-W/O LABEL)-USA Withdrawn
PT-72 Withdrawn
3-WAY STOPCOCK WHITE PKG Withdrawn
LS2 – T SITE ADD-ON KIT Withdrawn
BTR60-40DL KIT (USA) Withdrawn
MV3-N ADD ON KIT Withdrawn
BTR 6012-3 DL (USA) Withdrawn
MV2-T SITE ADD ON KIT (USA) Withdrawn
BTR40 LS2-S (USA) Withdrawn
BTR-6012-MV (VA SLC) Withdrawn
PT-36 Withdrawn
BTR2-6012-3 (USA) Withdrawn
BTR 24-40(USA) Withdrawn
BTR-3(USA) Withdrawn
BTR-30 (N/S & BULK PACK)-CARDIOMED Withdrawn
COVERED NEEDLELESS CANNULA (USA) Withdrawn
BTR2-6012-MV (VA SLC) Withdrawn
PT-60 Withdrawn
BTR40 LS3-MV (USA) Withdrawn
BP3 LS3-MV (USA) Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 381
Medex ICU Medical, Inc 225
Transpac™ ICU Medical, Inc 117
Antmed Shenzhen Antmed Co., Ltd. 96
Namic Navilyst Medical, Inc. 60
Namic Medline Industries, Inc. 58
Transpac™/Transtar™ ICU Medical, Inc 58
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 28
Centurion Centurion Medical Products Corporation 23
Transducer, Blood-Pressure, Extravascular Utah Medical Products, Inc. 22
Deltran Utah Medical Products, Inc. 22
Unimed Unimed Medical Supplies Inc 17

Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer