Pneupac
GTIN for 500-A4843, Medrail Clamp with Screws, 1/EA
4manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K043495 |
| Record published | 2020-05-06 |
| Record revised | 2025-04-16 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 25 to 95 % RH; Handling environment humidity 25 to 95 % RH; Handling environment atmospheric pressure 465 to 1100 KiloPascal; Handling environment temperature -10 to 50 °C; Storage environment atmospheric pressure 465 to 1700 KiloPascal |
| Packaging | Carton of 10, bag of 10, case of 5, box of 10, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100/905/320-CH | In distribution | |
| 530A1167NONEU | In distribution | |
| 123000 | In distribution | |
| 520A1125NONEU | In distribution | |
| 150003V | In distribution | |
| 520A1300US | In distribution | |
| 100/905/302-CH | In distribution | |
| V200DNUS | In distribution | |
| 530A1167NFRNONEU | In distribution | |
| 122202 | In distribution | |
| 130002 | In distribution | |
| 530A1166NFRNONEU | In distribution | |
| 500-A4844/MRI | In distribution | |
| 122203 | In distribution | |
| 510A1960NONEU | In distribution | |
| 130003 | In distribution | |
| 120002 | In distribution | |
| B100NUS | In distribution | |
| P300NUS | In distribution | |
| 120003 | In distribution | |
| 520A1299US | In distribution | |
| P310NUS | In distribution | |
| WW331002S | In distribution | |
| 123004 | In distribution | |
| 130002V | In distribution | |
| VR1AIRNUS | In distribution | |
| 123001 | In distribution | |
| 124003 | In distribution | |
| 100/905/341-CH | In distribution | |
| 122003 | In distribution | |
| P200DNUS | In distribution | |
| 530A1166NONEU | In distribution | |
| 100/905/300-CH | In distribution | |
| 500-A4843 | In distribution | |
| 100/905/301-CH | In distribution | |
| 122002 | In distribution | |
| 530A1167 | In distribution | |
| 520A1126NESNONEU | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Support Products | Allied Medical LLC | 50 |
| Neo-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 45 |
| Allied Medical LLC | Allied Medical LLC | 19 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 18 |
| AincA | Anesthesia Associates, Inc. | 17 |
| Neo-Tee T-Piece Resuscitator Circuit | Mercury Medical Enterprises, LLC | 12 |
| Life Support Products (LSP) | Allied Medical LLC | 12 |
| Moves | Thornhill Research Inc. | 11 |
| Ventlab | Ventlab, LLC | 7 |
| Resusa-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 7 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Macs | Airon Corporation | 4 |
Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Pm, Inc. | 510(k) number | 2007-05-16 | Not classified | Other | Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuou | 93 | 2008-10-10 |
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.