Nurse Combo Pocket Pal II™
Nurse Set 116/641 Combo,Frosted Magenta, Disp pkg
64manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (26), Jiangsu (13), Shanghai (7). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Vapo Healthcare Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Xiantao Junhui Plastic Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 64. All 64 manufacturers in China registered for Stethoscope, Manual
Record
| Listed by | American Diagnostic Corp., United States |
|---|---|
| FDA product code | LDE |
| Device type | Stethoscope, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 870.1875 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2024-11-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Master case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 116-641FMQ | In distribution | |
| 116-647BKQ | In distribution | |
| 116-647VQ | In distribution | |
| 116-641FPBQ | In distribution | |
| 116-670NQ | In distribution | |
| 116-641NQ | In distribution | |
| 116-641RBQ | In distribution | |
| 116-641VQ | In distribution | |
| 116-670DGQ | In distribution | |
| 116-647DGQ | In distribution | |
| 116-641FPLQ | In distribution | |
| 116-670BKQ | In distribution | |
| 116-670VQ | In distribution | |
| 116-647NQ | In distribution | |
| 116-641BKQ | In distribution | |
| 116-641DGQ | In distribution | |
| 116-647RBQ | In distribution | |
| 116-670RBQ | In distribution | |
| 116-641FIQ | In distribution | |
| 116-641FKWQ | In distribution | |
| 116-641TLQ | In distribution | |
| 116-670TLQ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adscope® | American Diagnostic Corp. | 737 |
| Proscope™ | American Diagnostic Corp. | 292 |
| MDF® | MDF Instruments Medifriend Inc. | 226 |
| Stethoscope | Rashman Corp. | 185 |
| 3M™ Littmann® | 3M Company | 118 |
| 3M™ Littmann® Classic III™ | 3M Company | 84 |
| Cardinal Health | Cardinal Health 200, LLC | 79 |
| 3M™ Littmann® Cardiology IV™ | 3M Company | 78 |
| Sklar® | Sklar Corporation | 55 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 53 |
| MediChoice | Owens & Minor Distribution, Inc. | 48 |
| Labtron | GF Health Products, Inc | 45 |
Showing 12 of 165. All products under Stethoscope, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K935944 | 1994-03-03 |
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.