Deltran
Disposable Pressure Transducer System, 2 Off 1 System (Enables Monitoring of Either of Two Lines with a Single Transducer), 3cc/hr Flow Rate, Micro Drip Chamber, 60" Lines
7manufacturers in China registered for this device type
22catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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.
| 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
| Listed by | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | DRS |
| Device type | Transducer, Blood-Pressure, Extravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2019-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 25, box of 10 |
| Sizes | Length 24 to 48 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Custom | Length 24 in | In distribution |
| Standard Single Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Single Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Kit | Flow Rate – 3 cc/hr | In distribution |
| II | Flow Rate – 30 cc/hr | In distribution |
| CUSTOM | Flow Rate – 3 cc/hr | In distribution |
| Standard Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Single Kit | Flow Rate – 3 cc/hr | In distribution |
| Custom | Flow Rate – 30 cc/hr | In distribution |
| Standard Single Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Bifurcated Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Bifurcated Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Trifurcated Kit | Flow Rate – 3 cc/hr | In distribution |
| Custom | Flow Rate – 3 cc/hr | In distribution |
| Standard Single Kit | Flow Rate – 3 cc/hr | In distribution |
| Custom | Length 48 in | In distribution |
| Standard Trifurcated Kit | Flow Rate – 3 cc/hr | In distribution |
| Standard Kit | In distribution | |
| Custom | Flow Rate – 3 cc/hr | In distribution |
| Standard Kit | Flow Rate – 3 cc/hr | In distribution |
| II | Flow Rate – 30 cc/hr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 381 |
| Medex | ICU Medical, Inc | 225 |
| Biotrans™ Pressure Monitoring Kits | Bioptimal International Pte. Ltd. | 134 |
| 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 |
| Unimed | Unimed Medical Supplies Inc | 17 |
Showing 12 of 145. All products under Transducer, Blood-Pressure, Extravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K864090 | 1987-03-20 |
| K842352 | 1985-03-25 |
| K841788 | 1985-03-25 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-06-04 | Class II | Packaging | Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices. | 1,800 kits | 2013-09-19 |
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.