Ventlab
GUDID 20889483080129
INFANT SAFE SPOT, MASK W/BAG RESERVOIR, MANO & 25CM POP-OFF
VENTLAB, LLC
Pulmonary resuscitator, manual, single-use| Primary Device ID | 20889483080129 |
| NIH Device Record Key | efe43e69-f96f-4117-acd2-2deb1bc7ede5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventlab |
| Version Model Number | BT2416 |
| Company DUNS | 038305402 |
| Company Name | VENTLAB, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com |
Device Dimensions
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Do not get wet. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889483080122 [Primary] |
| GS1 | 20889483080129 [Package] Contains: 10889483080122 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953107
FDA Product Code
| BSJ | Mask, Gas, Anesthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-21 |
| Device Publish Date | 2016-11-21 |
On-Brand Devices [Ventlab]
| 20889483113650 | SMALL ADULT RESUS, NO MASK, COLLAP RESERV |
| 20889483113643 | SMALL ADULT RESUS W/MASK, BAG RESERV,FILTER,PEEP AND FENEM |
| 20889483113629 | INFANTBAG,2MASK W/CORR.TUB,PEEP&BUILT-IN MANOMETER |
| 20889483113605 | INFANT RESUS BAG W/MANOMETER,MASK,FILTER AND FENEM |
| 20889483113582 | INFANT BAG W/MANOMETER,MASK & BLOW-BY |
| 20889483113544 | PEDIATRIC BAG, D2,D3,D4 MASK W/INFLATABLE BAG 02 RESERVOIR |
| 20889483113247 | HYPERINFLATION SYS, SIZE 1&2MS |
| 20889483113223 | 1/4 LITER HYPER SYSTEM W/MANOMETER & 7' SALTER TUBING |
| 20889483113100 | ADULT BAG, MASK W/INFLATABLE BAG RESERVOIR, PEEP & FLEX NECK |
| 20889483113087 | PEDIATRIC BAG, MASK W/ INFLATABLE 02 RESERVOIR, P/OFF W/MANOMETER |
| 20889483113063 | Anti-Static Spacer w/ #2 Mask |
| 20889483113056 | BreatheRite, Collapsible w/ Intersurgical Size 2 Mask |
| 20889483113018 | INFANT AIRFLOW W/MANOMETER & PEEP VA |
| 20889483112998 | PEDIATRIC BAG W/FILTER, MANOMETER, POP-OFF, MASK & FENEM |
| 20889483112974 | PEDIATRIC RESUS BAG W/MANOMETER, MASK AND PEEP VALVE |
| 20889483112950 | ADULT W/MANOMETER,MASK,O2 CONN,PEEP A |
| 20889483112943 | ADULT AIRFLOW, MASK W/CORRUGATED TUBING RESERVOIR, 14' TUBING & FENEM |
| 20889483112936 | ADULT AIRFLOW W/PEEP,FLEX NECK |
| 20889483112929 | ADULT AIRFLOW RESUSCITATOR |
| 20889483112615 | BreatheRite Rigid MDI Chamber |
| 20889483112226 | SM ADULT BAG, MASK W/ INFLATABLE BAG RESERVOIR, PEEP & FILTER |
| 20889483112158 | INFANT BAG, 2 MASK W/INFLATABLE BAG,MANOMETERBLOW-BY& EMS PEEP |
| 20889483112110 | INFANT RESUS W/MANOMETER, 2MASK,GREEN FI |
| 20889483112059 | SM ADULT RESUS BAG W/MASK |
| 20889483112035 | INFANT BAG W/MANOMETER, MASK & FILTER |
| 20889483112028 | INFANT BAG,D1MASK W/CORRUGATED TUBING RES&BUILT-IN MANOMETER |
| 20889483111908 | PEDIATRIC BAG, MASK W/COLLAPSIBLE ACC. & POP-OFF |
| 20889483111885 | PEDIATRIC BAG, MASK W/COLLAPSIBLE ACC. & PEEP VALVE |
| 20889483111878 | PEDIATRIC BAG, MASK W/ CORRUGATED TUBING RESERVOIR & FLEX NECK |
| 20889483111854 | INFANT STAT CHECK, MASK W/ CORRUGATED TUBING RESERVOIR & MANOMETER |
| 20889483111748 | Universal Circuit with B/V Filter |
| 20889483111694 | INFANT STAT CHECK,MASK,CORRUGA |
| 20889483111472 | SM ADULT BAG, MASK W/COLLAPSIBLE ACC, MANO & STAT CHECK |
| 20889483111403 | SMALL ADULT RESUS W/VERIFY, MASK, ACE |
| 20889483111335 | SMALL CHILD BAG, MASK W/ INFLATABLE 02 RESERVOIR & MANOMETER |
| 20889483111274 | Anti-Static Spacer |
| 20889483111243 | SMALL ADULT RESUS BAG W/MASK & BAG RESERV |
| 20889483111236 | SM CHILD BAG,3 MASKS W/CORRUGATED TUBING RESERVOIR, FILTER, MANO& NO BLOWBY |
| 20889483111212 | INFANT RESUS /STAT-CHECK,2 MASK |
| 20889483111205 | INFANT BAG,2 MASK W/CORRUGATED TUBING & BUILT-IN MANOMETER |
| 20889483110963 | PEDIATRIC BAG, MASK W/ INFLATABLE BAG RESERVOIR, POP-OFF, MANOMETER & FILTER |
| 20889483110932 | PEDIATRIC BAG, MASK W/INFLATABLE BAG 02 RESERVOIR,PEEP & POP-OFF |
| 20889483110871 | 1/2 LITER HYPER W/SIZE 0,1,2 MASKS |
| 20889483110864 | 1/2 L HYPER SYS,MANOMETER,NO POP-OFF |
| 20889483110857 | 1 LITRE HYPERINFLATION BAG SYSTEM W/ MANOMETER |
| 20889483110840 | PEDIATRIC BAG, D2,D3 MASK W/INFLATABLE BAG 02 RESERVOIR |
| 20889483110772 | INFANT BAG,2 MASK W/CORRUGATED TUBING RESERVOIR,25CM POP-OFF, MANOMETERNO BLOWBY |
| 20889483110765 | INFANT BAG,MASK W/CORRUGATED TUB,PEEP&BUILT-IN MANOMETER |
| 20889483110758 | RESUS. W/MANOMETER, MASK, PEEP & D1 |
| 20889483110741 | INFANT W/MANOMETER, PEEP ATTACHED,2 MASK |
Trademark Results [Ventlab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENTLAB 76431033 2763787 Live/Registered |
VENTLAB, LLC 2002-07-12 |
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