| Primary Device ID | 20884521540641 |
| NIH Device Record Key | 0b83526c-4eee-4ebb-917d-2c3598b119df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Newport Medical |
| Version Model Number | BCD43801P-EL |
| Catalog Number | BCD43801P-EL |
| Company DUNS | 050334275 |
| Company Name | Newport Medical Instruments, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Device Size Text, specify | 0 |
| Length | 180 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place; |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in Cool Dry Place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521540644 [Primary] |
| GS1 | 20884521540641 [Package] Contains: 10884521540644 Package: CASE [10 Units] In Commercial Distribution |
| CAI | Circuit, breathing (w connector, adaptor, y piece) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-09-20 |
| 10884521649934 | Permanent Adult/Ped Circuit W/O Water Trap and Exhalation Valve |
| 10884521542471 | REUSABLE PED CIRCUIT W/O PROX |
| 10884521542440 | REUSABLE INFANT CIRCUIT W/PROX |
| 10884521542402 | REUSABLE ADULT CIRCUIT W/O PRO |
| 10884521542013 | REUSBLE 15MM CCT, W/WT |
| 10884521541993 | REUSBLE 22MM CCT, W/WT |
| 10884521541986 | PED-ADLT REUSBLE NT CCT W/EXHV |
| 10884521541979 | PED-ADLT REUSBLE NT CCT W/EXHV |
| 10884521644700 | Universal (22mm ID) Ventilation Breathing Circuit Without Water Trap |
| 20884521540511 | Pediatric (15 mm ID) Abbreviated (Partical) J Ventilation Breathing Circuit |
| 10884521644717 | Universal (22 mm ID) J Ventilation Breathing Circuit |
| 20884521540641 | 180"" Universal (22 mm ID) J Ventilation Breathing Circuit Without Water Trap |
| 10884521644694 | Universal (22 mm ID) Abbreviated (Partial) J Ventilation Breathing Circuit |
| 10884521644687 | Universal Ventilation Breathing Circuit |
| 10884521644670 | Universal (22 mm ID) J Ventilation Breathing Circuit |
| 20884521540542 | 180"" Pediatric (15 mm ID) J Ventilation Breathing Circuit Without Water Trap |
| 10884521644663 | Pediatric Ventilation Breathing Circuit |
| 10884521541399 | Filter, Bacteria |
| 10884521511903 | E360 VENTILATOR WITH ACCESSORIES S MODEL |
| 10884521541467 | Filters |
| 10884521542389 | Oxygen Analyzer |
| 10884521649941 | Perm. 15MM/Ped Circuit W/O Water Trap and Exhalation Valve |
| 10884521542396 | REUSBLE ADLT CCT W/PROX, HTD W |
| 10884521544444 | KIT, PED/ ADULT AIRWAY FLOW SENSOR, BOX OF 4 |
| 10884521542037 | PROXIMAL INLINE FILTER PK OF 5 |
| 10884521542617 | Medical Oxygen Sensor |
| 10884521542464 | REUSABLE INFANT CIRCUIT W/O PR |