GELFOAM-JMI™ Powder Kit
GUDID 00360793410104
Absorbable Hemostatic Sponge, Collagen Based (GELFOAM Absorbable Gelatin Powder and Thrombin, Topical (Bovine) U.S.P., Thrombin-JMI®, 5,000 International Units)
PFIZER INC.
General surgical procedure kit, medicated| Primary Device ID | 00360793410104 |
| NIH Device Record Key | e1775fc1-a885-4251-bc37-380818d16536 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GELFOAM-JMI™ Powder Kit |
| Version Model Number | 1 g Powder |
| Company DUNS | 829076566 |
| Company Name | PFIZER INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
Customer Support Contacts
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| karena.arroyo@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com | |
| Phone | +1(484)865-6166 |
| UDICompliance@pfizer.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00360793410104 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N18286
FDA Product Code
| LMF | Agent, absorbable hemostatic, collagen based |
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 | 2018-07-06 |
| Device Publish Date | 2017-06-05 |
Devices Manufactured by PFIZER INC.
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| 00305733010020 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP S/M 8HR 2CT |
| 00305733010037 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 2CT |
| 00305733010075 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010389 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010396 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 10CT |
| 00305733010969 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP L/XL 8HR 3CT |
| 00305733010983 - ThermaCare HeatWraps | 2020-06-08 THERMACARE LOWER BACK & HIP 8CT + NECK/SHOULDER/WRIST 1CT |
Trademark Results [GELFOAM-JMI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELFOAM-JMI 98793960 not registered Live/Pending |
Pharmacia & Upjohn Company LLC 2024-10-10 |
 GELFOAM-JMI 87374475 5581577 Live/Registered |
Pharmacia & Upjohn Company LLC 2017-03-16 |
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